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A Practical Guide for PD Prescription Management and PD Adequest CONTENTS

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A Practical Guide for PD Prescription Management and PD Adequest

CONTENTS

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1

Section 1

GETTING STARTED

A Practical Guide for PD Prescription Management & PD Adequest

1

Dear Health Care Practitioner,

This Practical Guide for PD Prescription Management & PD Adequest resource tool is proudly sponsored by Baxter Corporation.

The aim of this practical guide is for you to have relevant information (relating to the provision of adequate dialysis for patients undergoing peritoneal dialysis) at your disposal.

In providing you with this manual, Baxter hopes to help improve the quality of care provided to patients, support safeguarding high standards of care, and help to create an environment in which clinical excellence will flourish.

The guidelines and recommendations included are designed to encourage the implementation of quality imperatives by allowing you to regularly reflect on your practice, and use up to date evidence to improve what you do.

We trust they will also help you to continually develop skills and knowledge, encourage teamwork to ensure improvements are made and put systems and processes in place.

Another very important aim is to include patients in decisions about their care, and encourage them to take an active role in improvement activities.

We have made every attempt to provide to you the balance of evidence, and the most up to date information. We do however recognize that the status quo does change, and that new information and guidelines will come to hand. This manual is therefore for you to use at your discretion.

Baxter does respect the fact that the ultimate decision making is that of the treating Health Care Professional.

Yours sincerely,

The Baxter Renal team

CONTENTS

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Section 1

GETTING STARTED

About this Guide

Chapter One focuses on PD Prescription Management with an emphasis on commencing and maintaining the effective management of a PD patient’s prescription.

Chapter Two focuses on the application of PD Adequest and its capabilities to assist clinicians with prescribing and managing PD patients. It is important to note that PD Adequest works within the scope of small solute, fluid removal, glucose absorption, and nutritional status.

This guide encompasses recent evidence and revised practice guideline recommendations from professional societies for peritoneal dialysis. It is intended to be used only as a guide and not as a replacement for clinical judgement.

This document draws upon various guidelines and recommendations from professional societies, organizations and published literature.

• International Society of Peritoneal Dialysis (ISPD)

• Canadian Society of Nephrology (CSN)

• The National Kidney Foundation Kidney Disease Outcome Quality Initiative (NKF KDOQI)

• British Renal Association

A Practical Guide for PD Prescription Management & PD Adequest

CONTENTS

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Section 1

GETTING STARTED

In 2011 - The CSN guidelines state:

"The group considered that adequate dialysis requires attention to volume status and nutrition as well as to clearances. Because volume status is critically related to blood pressure and other cardiovascular (CV) risk factors, it was felt to be important to address those topics also. Indeed, given the high cardiac mortality rates of dialysis patients, no area in their care is more worthy of focus than CV risk reduction. Clearances, volume, and nutrition are all profoundly influenced by residual renal function (RRF), and so a section on preservation of RRF has been given a prominent position. Glycemic control and the broader issue of the consequences of exposure to hypertonic glucose are also addressed."41

Blake P, Bargman J, Brimble S, Davidson S, Hirsch D, McCormick B, Suri R, Taylor P, Zalunardo N, Tonelli M, et al. Canadian Society of Nephrology Guidelines/Recommendations - Clinical Practice Guidelines and Recommendations on Peritoneal Dialysis Adequacy 2011. Peritoneal Dialysis International Vol 31, pp. 218-239.

It is very important to note that PD adequacy is broadly defined and should be interpreted clinically rather than focusing on solute and fluid removal only.33

ISPD guidelines/recommendations-Guideline on targets for solute and fluid removal in Adult patients on Chronic Peritoneal Dialysis Perit. Dial. Int., Vol. 26, pp. 520–522

A Practical Guide for PD Prescription Management & PD Adequest

CONTENTS

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Contents

SECTION 1 – PD PRESCRIPTION MANAgEMENT guIDE FOR ADulT PATIENTS

Introduction 8

getting Started

Establishing the First Prescription 10

Body Size 12

Residual Renal Function 13

Peritoneal Membrane Transport Type 15

The Initial Prescription

Overview of the Prescription Management Process 18

Initial Prescription 19

Suggested Timetable for Initial and Subsequent Clearance Measurements 20

Individualizing the Therapy

Achieving Adequate Fluid Balance 22

Achieving Minimum Recommended Small Solute Clearances 23

Clinical Review Visit 24

Monitoring the Therapy long Term

Residual Renal Function 26

Volume Control 28

Routine Clinical Review 29

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Contents

SECTION 2 – INTRODuCTION TO PD ADEquEST

Overview of PD Adequest 31

Entering Data; Overview of the PD Adequest Modules

24 Hour Collection Module 36

PET Module 43

Managing Prescriptions with PD Adequest

Regimen Module 47

Working with Individual Reports

Different Types of Reports that are Available 50

PET Curves 54

group Reports - Continuous quality Improvement - Which Patients Need Special Attention?

Population Selection 57

Customising and Setting Targets 58

QA Reports 59

Group Reports 60

Group Graphs 63

Clinical Validation of PD Adequest

Creatinine Correction factor 65

Expiry Dates 68

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Contents

SECTION 3 – glOSSARy

SECTION 4 – APPENDIx

International Clinical Practice Guideline Recommendations 80

Body Surface Area 81

Volume of Distribution (Vd Area) 83

Peritoneal Equilibration Test Procedure 87

Modified Peritoneal Equilibration Test Procedure 88

APD Regimens Examples 89

Patient Daily Records 90

Assumptions on which Modelling is based 91

Suggested Prescriptions for Patients 92

SECTION 5 – REFERENCES AND ADDITIONAl INFORMATION

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Patient Pathway to First Prescription

Body Size

Residual Renal Function

Peritoneal Membrane Transport Type

GETTING STARTED

Section 1

PD PRESCRIPTION MANAgEMENT guIDE FOR ADulT PATIENTS

Section 1

CONTENTS

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8

PD PRESCRIPTION MANAgEMENT guIDE

Introduction

This PD Prescription Management Tool is based on currently available scientific evidence and clinical practice guideline recommendations from professional societies. It is intended to be used only as a guide in the management of adult patients receiving peritoneal dialysis and is not a replacement for clinical judgement. Moreover, specific individual circumstances of your patients need to be taken into consideration, as well as specificities of guidelines of local nephrology societies or similar associations.

Original clinical practice tools focused on the peritoneal dialysis prescription in terms of small solute removal. However, two prospective randomized trials (one from Mexico and the other from Hong Kong) altered the focus on examining only small solute removal.1, 2 There is an increasing awareness of the importance of fluid balance in PD patients and achieving adequate ultrafiltration to maintain euvolemia.

This tool has been designed to guide the writing of an individualized prescription considering the key underlying parameters, patient size, residual renal function and peritoneal transport characteristic.

Computerized prescription management aids can be used to model variants of solute clearance levels, allowing analysis of differing prescription combinations.

However, the importance of clinical assessment needs also to be emphasized and it is also important to balance the impact of possible change in the PD prescription with the individual patient’s situation.

The tool is an aid for physicians and nurses caring for patients on PD and includes guidance on:

• Achieving targets to maintain adequate fluid balance and small solute clearance

• Monitoring patients on PD

• Preserving residual renal function

• Useful formulae and information for calculating small solute clearances as well asclinical aspects of various Continuous Ambulatory Peritoneal Dialysis (CAPD) and AutomatedPeritoneal Dialysis (APD) regimes

8

CONTENTS

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APPENDIX

GETTING STARTED

Establishing the First Prescription

Body Size

Residual Renal Function

Peritoneal Membrane Transport Type

CONTENTS

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gETTINg STARTED

Establishing the First Prescription

Adequacy and ultrafiltration Targets3,4

• Adequacy targets for dialysis should include both solute and fluid removal.

• The minimum target for combined renal and peritoneal target for smallsolute clearance is:

• Kt/Vurea = 1.7/ Week

If your unit refers to CSN guidelines or NKF KDOQI guidelines. 3, 41

– A separate target for creatinine clearance is not required in CAPD. In APD, due to a more

variable relationship between urea and creatinine clearance, an additional target of 45 L/

week/1.73 m2 for creatinine clearance is recommended in ISPD guidelines. 40

• Maintaining adequate fluid balance is critical to optimize patient outcomes.

• In regards to Ultrafiltration (UF) targets there are published recommendations from 3 organizations.Please refer to International Clinical Practice Guidelines Recommendations (Appendix 1, page 84)to view these recomendations.

• When targets are not achieved: monitor for signs of uraemic symptoms, over or underhydration and malnutrition. Relevant PD prescription changes should be considered.

• Plasma bicarbonate should be maintained within the normal range; this can be achieved in thevast majority of patients by adjusting the dialysis dose and/or dialysate buffer concentration.Occasionally bicarbonate buffered solutions will be required. Please refer to UK Clinical PracticePD Guideline Recommendation (Guideline 6.2)

CONTENTS

48

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GETTING STARTED

Establishing the First Prescription

Patient Pathway to First Prescription

1. Insert PD catheter in a timely way and flush in theatre. If possible do not use for 2 weeksbefore starting PD.4

2. Keep catheter immobilized as much as possible and do not flush.5

3. Commence PD training - CAPD or APD according to patient and clinician choice.

4. Set first prescription for CAPD or APD based on:a. patient sizeb. amount of residual renal function

5. See the patient 1 week after commencing PD at home to assess clinical and laboratory parameters.

Individually tailored prescriptions are essential for good prescription practices. Knowledge of the patients’ Body Surface Area (BSA), Residual Renal Function (RRF), and Peritoneal Membrane Type are fundamental to the PD prescription. These three parameters are required to appropriately use this Peritoneal Dialysis Prescription Management guide. Assessment of these factors are described on the following pages.

CONTENTS

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gETTINg STARTED

Body Size

Body Surface Area (BSA)

Body size affects the amount of dialysis a patient requires. Generally, larger patients require a larger dose of dialysis to achieve adequate small solute clearance. A simple measure of body size is the BSA. The table in Appendix 2 (page 85) or the following formula6 can be used to determine the patient’s BSA (m2).

Body Surface Area = 0.007184 x (Patient’s Height, cm)0.725 x (Patient’s Weight, kg) 0.425

Normalization of adequacy measures for body size

To compare small solute clearances between patients the clearance value is normalized to a function of patient size. Traditionally, for urea, its volume of distribution (V), is used and calculated from body weight, age and height (See Appendix 3-7, pages 86-90).

- Note that V can be underestimated in fluid overloaded and/or malnourished patients. Creatinineclearance is traditionally normalized to a patients’ BSA.

The relationship between V and BSA is not linear and especially not in obese patients, V increases out of proportion to BSA. So in the obese patient who has a low urea Kt/V it is important to examine the creatinine clearance as well before changing a prescription7.

CONTENTS

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GETTING STARTED

Residual renal function contributes significantly to the maintenance of euvolemia and to small solute and middle molecule clearances.8 It is important to measure and preserve this function in patients with chronic kidney disease and in patients receiving PD or Haemodialysis (HD).

There is evidence that RRF is associated with increased patient survival in studies where both peritoneal and kidney components are measured.3, 8 When the CANUSA data was re-analyzed, it became evident that it was kidney clearance and urine volume that predicted survival in PD and not peritoneal clearance.

Each 250ml decrease in 24 hour urine volume was associated with a 36% increase in relative risk (RR) of death, and 5l per week greater residual glomerular filtration rate (gFR) decreased the risk of mortality by 12%.9

Benefits of RRF preservation include:

• Facilitation in achieving euvolemia through removal of salt and water 10

• Improvement in blood pressure control 11

• Stabilization of left ventricular hypertrophy (LVH) 12

• Contribution to middle molecule clearances including beta 2-microglobulin 13

• Better nutritional status 14

• Improvement in phosphate control 15

• Contribution to total solute clearance 13

• Improved quality of life 16

It is crucial to adjust the PD prescription over time taking into account the loss of RRF so that dialysis does not become inadequate.

Residual Renal FunctionRESIDuAl RENAl FuNCTION

CONTENTS

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gETTINg STARTED

Peritoneal Membrane Transport Type

Peritoneal membrane transport type is important to consider when individualizing patient prescription. The Peritoneal Equilibration Test (PET) is used to define the membrane transport characteristics. Four different membrane types are identified based upon the 4-hr equilibration between dialysate (D) and plasma (P) creatinine and glucose, as shown below. 19

D/P Creatinine D/D0 glucose

HIgH .82 - 1.03

.65 - .81

.50 - .64

.34 - .49

HIgH AVERAgE

lOW AVERAgE

lOW

Membrane Transport type

4-Hour D/PCreatinine

Adapted from: Twardowski ZJ, Clinical Value of Standardized Equilibration Test in CAPD Patients, Current Concepts of CAPO, Blood Purif 1989;7:95-108.

The transport types of “low” to “high” are also referred to as “slow” to “fast” by some clinicians.

CONTENTS

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GETTING STARTED

Peritoneal Membrane Transport Type

PET Results19

• The PET gives the membrane transport type of the patient (based on D/P creatinine) andultrafiltration capacity.

• The ultrafiltration capacity helps to define ultrafiltration failure and at 4 hours should be:- 2L 2.5% > 200 mL- 2L 4.25% > 400 mL

• The PET results should be recorded in the patients health care record for comparing resultsover time.

If discordance in D/P creatinine and D/D0 glucose is noted, it is recommended to repeat the PET. Clinical assessment must be taken into account if results remain discordant.

Assessing Peritoneal Equilibration Test (PET)

• A PET should be performed 4-8 weeks after initiating peritoneal dialysis. 3

• The PET should be deferred at least 4 weeks and preferably for 8 weeks after resolution of aperitonitis episode. 3

• A PET can be done using either 2 litres of 2.5% or 4.25% and should always be done after aglucose dwell (CAPD or APD) and not following a dwell with a dry abdomen or icodextrin.(If PD Adequest is used 2.5% is preferred - see Simulated vs. Actual PET in section two of thisfolder).

• The PET assesses both small solute clearance (the D/P creatinine) and ultrafiltration(ultrafiltration capacity).

• For an overview of the PET and modified PET procedure, refer to Appendix 9 -10 on pages 92-93.

gETTINg STARTED

PET Calculations 19

D/P Creatinine = Corrected Creatinine Dialysate Concentration at 0-Hr, 2-Hr, 4-Hr dwell

Creatinine Plasma Concentration at 2-Hr dwell

D/DO glucose = Dialysate Glucose Concentration at 2-Hr and 4-Hr dwell

Dialysate Glucose Concentration at 0-Hr dwell

CONTENTS

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APPENDIX

GETTING STARTED

Overview of the Prescription Management Process

Initial Prescription

Suggested Timetable for Initial and Subsequent Clearance Measurements

THE INITIAl PRESCRIPTION

“Quote goes herequote goes here.”Name

“...individualizing the prescription is the key toimproving the patient outcome and long-term PD therapy success.

The challenge to the PD practitioners is to make prescription management an integral part of everyday patient management.”Ad Hoc Committee on PD Adequacy 20

CONTENTS

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THE INITIAL PRESCRIPTION

Overview of the Prescription Management Process

AIM

The key to PD Prescription Management is to AIM for a treatment regime that optimizes patient’s outcomes and quality of life. So the cycle described below can be used in clinical practice.

THE INITIAl PRESCRIPTION

CONTENTS

Individualize

Individualize

m

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Initial Prescription

Assessing for Initial Prescription

Patient Size(using BSA)

Clinical AssessmentParticular attention to volume

status

Consider patients preferences and lifestyle (CAPD or APD)

Aim for the lowest glucose concentration solutions possible but adjust PD prescription to volume status

Set Initial Prescription

urinary Output

*APD

**APD3-4 cycles/night x1.5-

2.5L fill volumes Total cycle time 8-10 hours

Day time DwellFill volume 1-2.5L

0-1 exchanges per dayDry day possible if

significant RRF

*CAPD

3-4 exchanges per 24h1.5-2.5L fill volumes

Example 1

• BSA 1.5m2, 1L urine output, no fluid overload

• CAPD= 3 x 1.5L or APD= 3 x 1.5L over 8 hours and 1.5L daytime dwell

• Check clinical status and clearance, increase prescribed volumesincrementally if required

Example 2

• BSA 1.7m2, 2L urine output, no fluid overload

• CAPD= 3 x 2.0L or APD= 3 x 2.0L over 8 hours and 1.5L daytime dwell

• Check clinical status and clearance, increase prescribed volumes incrementally if required

Example 3

• BSA 2.1m2,1L urine output, no fluid overload

• CAPD= 4x 2.0/2.0L or APD=3 x 2.5L over 8 hours and 2.0L daytime dwell

• Check clinical status and clearance, increase prescribed volumes incrementally if required

For additional examples of various APD regimens, refer to Appendix 11, page 94.

*CAPD/APD• # Patients with sufficient RRF(>2mL/min/1.73m2 BSA) can use smaller fill volumes (1.5-2L)

• Anuric patients should use larger fill volumes (2-2.5L)

**APD• Consider increasing frequency of cycles in patients with low RRF

THE INITIAl PRESCRIPTION

CONTENTS

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THE INITIAl PRESCRIPTION

Suggested Timetable for Initial and Subsequent Clearance Measurements

The following table is meant as a guide for assessing adequacy of the PD prescription based upon CSN Guidelines41. Depending on patient status, more frequent monitoring may be necessary with subsequent prescription adjustment.

Peritoneal and Renal Kt/V and 24 hour UF

PET

■ Initial assessment: 2-4 weeks after dialysis initiation

■ Every 3-6 months or if clinically indicated

■ 2 weeks after a prescription change

■ A 24 hour urine collection for volume and clearance isrequired every 2 months for patients with a urine output> 100 mls

■ Baseline 4-8 weeks after starting PD

■ After that and whenever clinically indicated*

■ PET testing is particularly important in APD patients

*The PET should be repeated if the following occur:

• Unexplained decrease in drain volume

• Persistent fluid overload/increase in blood pressure

• Increased need for hypertonic exchanges despite fluid/salt intake restriction

• Decrease in peritoneal solute clearance

• Uremic symptoms

Patient Education and Monitoring At Home

During patient education as PD is commencing, it is important that the patient understands the relationship between the PD treatment/prescription, their urine output, weight and blood pressure.

Patients should be encouraged, based on guidance from the dietician/nurse/physician, to manage their own fluid balance and learn about restricting salt and fluid intake. They should also be trained in how to vary their PD prescription as required.

Record keeping of each day’s PD treatment, body weight, blood pressure and if diabetic, blood sugar level is vital and should be kept by the patient as a reference. An example is presented in Appendix 12 on page 95.

This record should be reviewed at each clinic visit and the patient should receive regular re-training on the importance of self monitoring.

CONTENTS

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Achieving Adequate Fluid Balance

Achieving Minimum Recommended Small Solute Clearances

Therapy Optimisation

Clinical Review Visit

INDIVIDuAlIZINg THE THERAPy

PD therapy should be based upon patient’s lifestyle, clinical status, ultrafiltration and clearances. The following pages suggest ways to achieve solute clearance and adequate fluid balance. Prescription management software can be helpful at determining the likely result of a prescription change and optimal prescription.

The actual results must be monitored regularly and the dialysis prescription adjusted using the principles outlined to try and achieve targets.

CONTENTS

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INDIVIDuAlIZINg THE THERAPy

Achieving Adequate Fluid Balance

Important Considerations for Achieving Adequate Fluid Balance

• Maintaining adequate fluid status is critically important in optimizing patient outcomes.

• Patients with fluid removal (combined peritoneal and renal) of less than 1L/day need closermonitoring for signs of fluid overload.

• Use the patients hand held record for each CAPD exchange or the output of the APD cycler(initial drain from daytime dwell and total night-time UF) as well as weight and urine output forassessing the current status.

– This approach determines where a problem lies - for example drop in urine output? Low UFin short dwells? Low UF in long dwells? Excessive UF? Diet and fluid intake?

• One should avoid any prescription which results in fluid reabsorption and also avoid using highdextrose concentration dwells regularly.

• TIP: Shortening dwell times can result in increased ultrafiltration, especially in patients with hightransport characteristics (e.g. reduce long day APD dwell to 8 -10 hours).

• 7.5% lcodextrin should be considered in patients with fluid overload related to insufficient UF inlong dwells (APD & CAPD) and to avoid excessive glucose exposure.4, 21

– Icodextrin is a non-glucose based product therefore reduces the daily glucose exposure

Physiology of ultra filtration with Icodextrin showing that with icodextrin this is prolonged and independent of membrane transport status.22

Further guidance is given in the algorithm on page 23.Adapted from Mujais S et al: Profiling of peritoneal filtration: Kidney Int 2002 (62), Suppl 81: S17-S22

length of dwells and uF

Physiology of ultrafiltration showing net ultrafiltration with 1.5% dextrose fluid. Shortening the dwell time could stop negative uF.22

CONTENTS

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INDIVIDuAlIZINg THE THERAPy

Achieving Minimal Recommended Small Solute Clearances

If the measured small solute clearance is less than desired or predicted after a recent prescription change, it is recommended you ensure that the 24-Hr dialysate and urine collections were done properly prior to changing the PD prescription. The below table provides general guidance with regards to increasing small solute clearance if Kt/V

urea target is not achieved.

The figure illustrates the need to increase the number of exchanges as D/P creatinine rises and to use higher fill volumes with higher body sizes.

In order to maximize solute removal, we would need to optimize fluid removal.

Therapy Optimization 3

Physicians who wish to use volume of urea distribution (Vurea) to individualize patient’s dialysis prescription, please refer to Appendix 13 - 15 on pages 96 - 98 for recommended prescriptions to achieve a Kt/Vurea of 1.7 and a minimum ultrafiltration of 1L/day.

• Increase fill volume (start during night timedwell due to supine position) 23, 24

• Higher transport status may require icodextrinto sustain UF during the long dwell

• For patients without residual renal function,large BSA, or high transport type, a fifthexchange may be helpful (monitor forcompliance and quality of life) 3

• Higher transport status patients may benefitfrom a switch to APD

CAPD

• Add a day time exchange 3

• Increase fill volume per exchange 23, 24

• Increase the duration of time on cycler therapy (e.g increased length of time and/or the number of night time exchanges) 3

• APD patients with significant RRF may not require a long day dwell 3

• Anuric APD patients may require “wet” days 3

• High transport patients usually require icodextrin or two short day time exchanges to sustain UF 3

APD

Small (<1.71 BSA)

Medium (1.71-2.0 BSA)

Large (>2.0 BSA)

CONTENTSCONTENTS

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INDIVIDuAlIZINg THE THERAPy

Clinical Review Visit 2, 3, 24, 39

Clinical Review Visit

Evaluate the adequacy of the prescription for the patient

Fluid Overload

Identify cause

Inadequate uF in short dwell

H/HA l/lA

• Increase fillvolume

• Increase totaltherapy time inAPD

• Increase thedextroseconcentration

H/HA l/lA

Inadequate uF in long dwell

Treat non prescriptive

related causes

Treat non prescriptive

related causes

• Decreasedextroseconcentration

• Adjustdwell time

• ConsiderceasingIcodextrin use

Prescription related

Non Prescription

related

Prescription related

Non Prescription

related

Dehydration

Identify cause

Kt/V≥1.7Adequate Fluid Status

Kt/V<1.7Adequate Fluid Status

Adjust prescription to increase small solute

clearance and reassess in 2 weeks

Clinical assessmentsatisfactory

Continue same

treatment prescription

Clinical assessment

Not satisfactory

Explore reasons and assess accordingly

• Increasefill volume

• increase thedextroseconcentration

• If on CAPDconsiderswitching toHD

• Increasefill volume

• Consider 2short daytimeglucose dwellsof 4-6 hours(in APD)

• Considericodextrin

• Increasefill volume

• Add a lastfill

• Increasedextroseconcentration

• Considericodextrin

CONTENTS

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Residual Renal Function

Volume Control

Routine Clinical review

MONITORINg THE THERAPy lONg TERM

After individualizing the therapy, it is important to monitor the patient and their adequacy parameters. It is also necessary to carefully monitor the patient’s compliance and satisfaction with the treatment. Any change in a prescription should be monitored by assessing UF from the patient diary and by measuring small solute clearance. Measurements can be done within one month on the new PD prescription.

CONTENTSCONTENTS

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MONITORINg THE THERAPy lONg TERM

Residual Renal Function

It is important to maintain RRF. This can be achieved by:

• Use of angiotensin converting-enzyme inhibitors (ACE-I) or AT1-receptor blockers (ARB) as firstline agents for hypertension, and as renal protection agents in normotensive patients27, 28. RRFand serum potassium should be monitored very closely.

• Avoiding dehydration or hypotensive episodes, caused by excessive UF.29

• Minimizing the risk for peritonitis by referring to credible international or local guidelines andimplementing guidelines in hospital protocols.3

• Minimize exposure to nephrotoxic agents (i.e. radiographic contrast, nonsteroidal anti-inflammatory drugs (NSAIDs), repeated or prolonged use of aminoglycosides).30

• Detect and treat urinary tract obstruction.3

• Avoid hypercalcemia.3

CONTENTS

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MONITORINg THE THERAPy lONg TERM

Residual Renal Function

Hypertension in dialysis patients often reflects extracellular fluid (ECF) volume expansion. Consequently, good blood pressure control requires optimization of volume status.

Currently the assessment of ECF volume status in End Stage Renal Disease (ERSD) patients remains a clinical judgment.

A practical approach is to reduce the target (‘dry’) weight until the patient is edema free and normotensive (i.e. < 140/90 mmHg) without medication (unless cardioprotective or renoprotective reasons); without postural hypotension, cramps, or excess fatigue.

Given the proven value of residual renal function, a falling urine output should prompt one to reconsider target weight reduction. In addition, dyspnea and edema may be due to other causes and need specific treatment.

Consider the following approach in achieving target weight in PD: non-peritoneal and peritoneal approaches in patients with fluid overload.3, 25,26

• A combination of these peritoneal and non-peritoneal approaches should be used to normalizevolume status.

• It should be noted that utilization of hypertonic glucose should be restricted in order to preservethe peritoneal membrane, limit calorie absorption and reduce cardiovascular risk profiles.

• Given that reduction of blood pressure is of critical importance, antihypertensive agents shouldbe added if a BP of 140/90 mmHg cannot be achieved by ECF volume reduction alone. Forreasons of renoprotection, ACE-Is and ARBs should be the initial anti-hypertensive agents used.

Non-pertioneal include

Protect RRF

High dose furosemide

Restriction of salt and/or fluid intake

Enhancement of patient compliance

Improve glycaemic control

Peritoneal approaches include

Check catheter function, signs of hernia/leaks (may require abdominal X Ray and/or CT Peritoneography to assess catheter position)

Evaluate UF - patient diary and PET

Consider Icodextrin for long dwell

Adjust dwell time/number of exchanges/dextrose concentrations

CONTENTSCONTENTS

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MONITORINg THE THERAPy lONg TERM

Volume Control

Volume Control

Assessment of Volume Status25

Euvolemia

yES

yES

Ongoing Evaluations

NO

Blood Pressure at Goal • Adjust Prescription to decreaseUF and/or adjust fluid intake

• Adjust the dose of diuretics

• Reduce use of anti-hypertensives ifapplicable

• Access for other sources of fluid loss

Hypervolemia

yESSee page 24

Hypovolemia

yES

Hypertension

Interventions

• Dietary evaluation

• Optimzation ofantihypertensivemedication

• Consider addingdiuretics

Hypotension

Interventions

• Increase fluidintake

• Decrease glucoseconcentration

• Reduce anti-hypertensivesmedication ifapplicable

• Considerreducing anti-hypertensives

CONTENTS

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MONITORINg THE THERAPy lONg TERM

Routine Clinical Review

During the hospital clinical review, the patients history, clinical examination and laboratory values should be carefully monitored for changes. Any decline in patient status may warrant a more thorough adequacy assessment involving a 24-Hr dialysate and urine collection. Residual Renal Function should be measured every two months with subsequent prescription adjustment if necessary.3

Routine Visit

Patient feels well and all

clinical/laboratory assessments are

satisfactory

Clinical Assessment3

• Comorbid disease• Nausea, vomiting,

fatigue• Nutritional assessment:

appetite, signsof protein-energymalnutrition

• Exit site examination• QoL (social,

psychological,professional, vitality,physical performance,quality of sleep)

• Medication review

yES

Continue without adjustment3

Routine review:• Renal clinic every

1-3 months• Check dialysis every

3-6 months41

NO

• Identify problem andact accordingly

• Adjust therapy as required• Assess compliance, further

assess and manageidentified issues

Volume status and Fluid removal26

• Presence of edema• BP and weight• Residual renal function• Salt and Fluid intake• Treatment records

(UF and glucose)• Compliance• Check catheter

function• Check delivery records

Clearance Assessment3

• 24 hour collections forurine and peritonealurea Kt/V and weeklycreatinine clearance

labroratory Assessment33, 41, 35, 46

• Routine chemistries toinclude:Blood electrolytesUreaCreatinineCalciumPhosphateHaemoglobinAlbuminquarterlyPTHAcid-Base balance: bicarbonateCRPIron studies

CONTENTSCONTENTS

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31

Patient Pathway to First Prescription

Body Size

Residual Renal Function

Peritoneal Membrane Transport Type

gETTINg STARTED

Section 2

INTRODuCTION TO PD ADEquEST

CONTENTSCONTENTS

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PD ADEquEST

Overview of PD Adequest

PD Adequest is a kinetic modelling software application created to calculate, report and predict the adequacy of PD regimens for individual patients as well as providing a reporting function. The reporting function offers both individual and group reports for easy patient review.

PD Adequest is a powerful therapeutic tool that can assist the clinician in predicting the patient outcome, when a PD fluid combination is prescribed. PD Adequest allows the comparison of various fictional prescriptions and the predicted patient outcome. The software incorporates a variety of techniques, while taking into account the current status of the patients peritoneal membrane. This comparator allows the clinician to consider what would be the most appropriate PD fluid prescriptions for any particular patient.

Knowledgeable application of PD Adequest coupled with sound bedside judgment will ensure a high quality of patient care.

Importance of Accurate Data Input

The precision with which fluid and solute removal for individual patients are predicted by PD Adequest will depend upon the precise collection and input of the individual’s clinical data. Errors in input will create inaccuracies in the model’s prediction. However, even when these estimates are not as accurate as desired, the results are still useful for a relative comparison of PD treatment regimens.

PD Adequest is a mathematical tool. It is not in any way intended to be a substitute for good clinical practice. Use of this software implies that the user agrees to the terms of the Baxter Software License Agreement provided with this software. For a complete description of the warranties associated with use of this software, please refer to the license agreement in the Help Menu.

CONTENTS

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PD ADEquEST

Overview of PD Adequest

The Help Menu is a very important and helpful resource for users of PD Adequest. You will find answers too many questions you may have about the use of the program and procedures related to PD Adequacy.

You can find the Help Menu at the furthermost right of the Menu Bar.

This section of the folder provides an overview of the most commonly used features of PD Adequest, for more detailed information; please refer to the help menu.

The help menu should be your first point of call when trouble shooting PD Adequest. Please contact your local Baxter representative if you require any further assistance

utilizing PD Adequest.

Help Menu

CONTENTSCONTENTS

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Overview of PD Adequest

PD ADEquEST

The Menu Bar and the Tool Bar

Menu Bar

The Toolbar:

The Toolbar is used for quick access to commonly used features in PD Adequest; all these options are also available in the Menu Bar.

Details: Patient demographic details

24-Hour: Use to bring up the latest 24 Hour collection result of the highlighted patient (note: use theMenu bar Collection New, to add a new 24 hour collection)

PET: Use to bring up the latest PET results of the highlighted patient

Regimen: Shortcut to the Regimen predictive module

Optimize: Shortcut to the Optimize predictive module

Nutrition: Useful Nutritional information

Centre: Customize the name of the Centre a patient is appointed to

Doctor: Use to add Doctors to PD Adequest

Nurse: Use to add Nurses to PD Adequest

group Reports: Shortcut to Group Report window.

Note: you must either select and existing patient from the patient list for these options to work or alternatively enter the details of a new patient

CONTENTS

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34

PD ADEquEST

Overview of PD Adequest

Modules in PD Adequest

There are essentially five modules in PD Adequest:

• 24-Hour Collection Module

• PET Module

• Reporting Module

• Regimen Module

On the following pages you will find a brief description of each of these modules.

CONTENTS

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36

gETTINg STARTED

DRAFT

24 Hour Collection Module

PET Module

ENTERINg DATA: OVERVIEW OF THE PD ADEquEST MODulES

CONTENTS

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36

24 Hour Collection Module

ENTERINg DATA: OVERVIEW OF THE PD ADEquEST MODulES

The 24- Hour Collection Module

PD Adequest itself cannot determine whether or not a PD patient is receiving adequate dialysis.

Rather, the program calculates clearances (Kt/V and creatinine clearance) and it is up to the clinician to decide whether these clearances constitute adequate dialysis for a patient.

There are 15 data entry fields on the 24-hour collection window. These fields can be separated into four types:

• Patient’s physical characteristics (height, weight, ideal body weight and amputee)

• Serum data

• Dialysate data (from a 24 hour collection of drained dialysate)

• Urine data (from a 24 hour collection of urine).

CONTENTS

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ENTERINg DATA: OVERVIEW OF THE PD ADEquEST MODulES

24 Hour Collection Module

By entering data into these fields, users can automatically calculate clearances, urea and creatinine generation rates, and normalized protein catabolic rates. In addition, when information about a new 24-hour collection is entered into the system, the results of that collection are automatically plotted on a variety of reports and graphs.

If you are entering the results for a patient that has had a historical 24-hour collection, it is important to click “New Collection” under the Collection menu found in the toolbar menu. This ensures you retain the results of previous collections.

A comprehensive database that outline’s recommended 24 hour collection and PET procedures can be found in the help menu under clinical procedures.

CONTENTS

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ENTERINg DATA: OVERVIEW OF THE PD ADEquEST MODulES

24 Hour Collection Module

Adding Ideal Body Weight to a Patient’s Record

Normalized Protein Catabolic Rate (nPCR) is a commonly accepted measure of nutritional status for dialysis patients. In previous versions, PD ADEQUEST used a patient’s actual body weight to normalize PCR. (Experts on nutrition informed Baxter that this method was limited in its usefulness. The current standard is to normalize to an ideal body weight. The Ideal Body Weight Window gives users the opportunity to select an ideal body weight for normalization of PCR.

Note: The ideal body weight is chosen by the user and is not suggested by PD ADEQUEST in any way.

Choosing an ideal body weight will not replace the patient’s actual body weight in the database, and will not have any effect on anything other than nPCR. The Estimated Total Body Water and BSA will be calculated using actual body weight.

CONTENTS

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ENTERINg DATA: OVERVIEW OF THE PD ADEquEST MODulES

24 Hour Collection Module

To use the patient’s Ideal Body Weight in the nPCR calculation, follow these steps:

1. Click any field on the patient’s record from the Patient List window.

2. Click the 24 Hour button. The 24 Hour Collection window is displayed

3. Click on the Ideal Body Weight button.

4. The Ideal Body Weight window is displayed.

5. In the Ideal Body Weight field, enter what you deem to be the ideal weight for the patient.

6. Click Apply.

7. Click Close.

8. The system will recalculate the Protein Catabolic Rate (nPCR) value.

Ideal body weight button

CONTENTS

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40

ENTERINg DATA: OVERVIEW OF THE PD ADEquEST MODulES

24 Hour Collection Module

Working With the Amputee Data Window

While accurate estimates of body surface area and body water are critical in the calculation of normalized creatinine clearance and Kt/V, common methods for estimating these parameters do not account for amputations. The Amputee Data window is intended to give you the ability to easily adjust these estimations, as well as normalize creatinine clearance and Kt/V to account for missing limbs.

Once data has been entered in this window, the system will:

• Correct estimations of body volume and body surface area for limbs missing due to amputation inadult patients. Note: this option is not available for paediatric patients.

• Copy the corrected values to the BSA and Estimated Total Body Water fields on the 24-HourCollection window.

• The values are then used to provide the V in the Kt/V calculations and as the normalizing factor forcreatinine clearance.

• Set the Applied from Amputee BSA and Applied from Amputee Est. Total Body Water flags in theOther Parameters section on the 24-Hour Collection window.

To create or modify data in the Amputee Data window, follow these steps:

1. Select the patient record from the Patient List.

2. From the Main Menu bar, double click the 24-Hour icon. The 24-Hour Collection windowis opened.

3. Click the Amputee button. The Amputee Data window is displayed.

4. The system displays the following read-only fields:

Gender – used as part of the calculation for estimating body water.

Age – used as part of the calculation for estimating body water.

Actual Height – used in the calculation of estimated BSA and body volume.

Actual Weight – used in the calculation of estimated BSA and body volume.

CONTENTS

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41

ENTERINg DATA: OVERVIEW OF THE PD ADEquEST MODulES

24 Hour Collection Module

5. The graphical representation of a human allows you to alter the body composition of your patientto reflect any amputated limbs.

• Click on the body part to remove.

• If you make a mistake, click the Reset Selected limbs button located in the lower portionof this screen. This will reset the graphical representation and all calculated fields.

• Arms may be altered at three locations –hand, forearm and upper arm. Removing the upperarm automatically removes the wrist and lower arm portion.

• Legs may be altered at three locations – foot, lower leg and thigh. Removing the thighautomatically removes the foot and lower leg.

• Head and trunk portions may not be altered. A warning message, “Removal of the head ortrunk is not allowed”, is displayed if these areas are accidentally clicked.

6. Once the graphical representation is altered, the system will update the % Weight Loss and % LostBSA values.

7. The % Weight Loss field indicates the percent of body weight of all body parts missing due toamputation. The values used by the system are displayed in the “Selected Limb Values” legend.Use the scroll bars to scroll through these values.

8. The % Lost BSA field indicates the percent of total BSA lost due to amputation. The values usedby the system are displayed in the Selected Limb Values legend displayed on this screen. Use thescroll bars to scroll through these values.

9. Height without Amp – this optional field can be used to enter the patient’s height as if he or shehad no amputations. If entered, this value will be used in the correction of estimated BSA andbody volume. If not entered, the actual height will be used in all calculations.

10. Click the Calculate button to activate the calculations for the following fields:

unadjusted Body Volume - the result of the estimated body volume calculation using theWatson & Watson method with the patient’s actual height and weight.

Body Weight w/o Amputations - the patient’s weight as if he or she had no amputations. This value will used in the correction of estimated BSA and body volume.

Est Body Volume w/o Amputations - the result of the estimated body volume calculation using the Watson & Watson method with the patient’s height and weight as if he or she had no amputations.

Volume / Weight - the patient’s estimated body water volume per kilogram of body weight prior to any amputations. This value is used in the correction of estimated body volume calculation.

unmodified BSA - the result of the BSA calculation using the Dubois & Dubois method for the current record using the patient’s actual height and weight.

CONTENTS

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ENTERINg DATA: OVERVIEW OF THE PD ADEquEST MODulES

24 Hour Collection Module

BSA Without Amputations - the result of the BSA calculation using the Dubois & Dubois method for the current record using the patient’s height and weight as if he or she had no amputations.

Corrected BSA - the result of the corrected BSA calculation.

11. Click Apply to Program to copy the Corrected Body Volume and Corrected BSA values to theEstimated Total Body Water and BSA fields and set the Applied from Amputee flags in the 24 HourCollection window.

12. Click References to display citations for all formulae referenced on this screen.

13. Click Reset Selected limbs and Apply Off to return the graphical representation to the originalstatus without amputations and delete all calculations generated by the calculate button.

To close this window and return to the 24-Hour Collection window, click the x button in the upper right corner of this window or click the Close button.

CONTENTS

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ENTERINg DATA: OVERVIEW OF THE PD ADEquEST MODulES

PET Module

The PET Module

The results of the Peritoneal Equilibration Test (PET) are a critical input into the PD Adequest model. Proper use of the PET allows clinicians to determine the transport characteristics of the patient’s peritoneal membrane and can give some insight into how effectively the patient will respond to different PD regimens in terms of clearances and ultrafiltration.

Each patient’s peritoneal membrane is unique. PD Adequest uses the PET, in conjunction with the results of a long dwell exchange, to determine the Mass Transfer Area Coefficients (MTACs) for urea, creatinine and glucose, as well as to determine certain water transport parameters for individual patients.

MTACS are essentially the speed at which different solutes move across the peritoneal membrane. MTACs are used in the Regimen and Optimization modules to predict an individual patients Kt/V, creatinine clearance and glucose absorption under different PD regimens.

More detailed information can be found in the PD Adequest help menu.

CONTENTS

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ENTERINg DATA: OVERVIEW OF THE PD ADEquEST MODulES

PET Module

The data for the PET can be separated into three categories:

• Overnight Exchange

• Four Hour Equilibration Data

• Sample Data from the PET.

It is very important that accurate PET data is inputted into PD Adequest – Try to be as specific as possible with the data that is entered. For example, if you were unable to obtain a serum data at exactly 120 minutes, ensure that you input the exact time the serum sample was obtained – this is fundamental to the accuracy of the mathematical predictive model in PD Adequest.

CONTENTS

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ENTERINg DATA: OVERVIEW OF THE PD ADEquEST MODulES

PET Module

Actual vs. Simulated (Adult Patients)

PET tests for adult patients are classified as Actual if they meet the following criteria:

• PET tests have fill volumes between 1,900 - 2,100 mL

• Dextrose/Glucose concentrations of 2.5%

• Dialysate creatinine values in sample two or sample three

• Serum samples drawn at 120 minutes (± 10 minutes)

• Dialysate samples drawn at 0, 120, and 240 minutes (± 10 minutes)

• Dialysate samples drawn at 0, 120, and 240 minutes (± 10 minutes)

PET tests that contain values outside the above ranges are classified as “Simulated PETs”

In this case, data displayed in the “PET Details” window is the result of predictive modelling that estimates what the D/P, D/D0, and drain volumes would have been had the conditions for an actual PET been met. In addition, data displayed on the Creatinine, Urea, and Glucose PET Curve graphs will be based on simulated data, not data entered on the actual PET window.

CONTENTS

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GETTING STARTED

47

MANAgINg PRESCRIPTIONS WITH PD ADEquEST

The Regimen Module

The Optimization Module

CONTENTS

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MANAgINg PRESCRIPTIONS WITH PD ADEquEST

The Regimen Module

Begin by selecting the desired modality you would like to model.

With each adjustment, the user can immediately obtain a prediction of how that change could effect the patients’ response to the proposed prescription change.

Note: Quantum PD refers to a device that delivered a bag exchange overnight to enable an increased dose to CAPD patients, this device is now obsolete in Australia, Canada and New Zealand.

The Regimen module

The Regimen module is one of two methods users can employ to use the PD Adequest predictive module to evaluate alternative PD regimens for their patients.

Once users have entered data on the 24-Hour Collection and PET Windows, the Regimen Module will be available to them. The Regimen module allows users to construct hypothetical CAPD, APD or Tidal PD regimens and examine how a patient may respond to each.

CONTENTS

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MANAgINg PRESCRIPTIONS WITH PD ADEquEST

The Regimen Module

Note: This example illustrates an APD Regimen Prediction

1. The modality that is being modelled

2. The number of daytime exchanges and volume of the daytime dwell(s)

3. The length of time of the daytime dwell (s)

4. The total volume of the night-time APD therapy

5. The number of exchanges during the night-time APD therapy

6. The time the therapy will be performed

7. The Dextrose concentration the prescription has been modelled

8. The weekly clearances (Urea L/week, CCL L/week, Urea Kt/V) for the modelled prescription

9. Predicted 24 hour fluid removal

10. Predicted 24 hour glucose absorption

11. Predicted “steady state” serum results for the modelled prescription

12. Click to Save the Regimen for the patient.

Tip: It is advisable to change one variable at a time to see what effect it has on the predicted clearances, ultrafiltration and glucose Kcal absorption.

Dialysis Dose

1 2 3 4 5 6 7 8 9 10 11 12

Predicted Clearances and UF

Modelled Prescription Prediction

CONTENTS

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gETTINg STARTED

Different Types of Reports that are Available

PET Curves

WORKINg WITH INDIVIDuAl REPORTS

CONTENTS

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WORKINg WITH INDIVIDuAl REPORTS

Different Types of Reports that are Available

Key Patient Data Individual Report

There are a variety of reports available in PD Adequest, from comprehensive to key patient data.

To access individual reports, highlight a patient then click Reports Individual.

Current Patient Individual Report

This option allows you to create a tabular report consisting of several sections that together give you an overall picture of the patient’s PD ADEQUEST 2.0 data as of the collection date noted in the current record.

Report Sections include:

• Section 1 – this section contains general patient information.

• Serum Concentrations – this section contains information regarding the patient’s blood chemistryas of the collection date.

• 24-Hour Dialysate and Urine Collection – this section contains information regarding the chemistryof the patient’s urine and drained dialysate as of the collection date.

• Calculated Values – this section contains information calculated from the 24-Hour Collectionrecord.

• Weekly Clearances – this section information calculated from the 24-Hour Collection record.Values are listed for Total, Dialysate and Residual clearances.

• Overnight Exchange, Four-Hour Equilibration Test, Data and Other Parameters all displayinformation taken from the PET window and related options.

• Note: The system will retrieve the most recent collection record for a patient.

CONTENTS

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WORKINg WITH INDIVIDuAl REPORTS

Different Types of Reports that are Available

To create this report, follow these steps:

1. Click to highlight the patient record from the Patient List.

2. Click to highlight the Collection Date record located in the lower portion of the screen.

3. From the PD Adequest Main Menu toolbar, click Individual Reports.

4. Click Current Patient.

5. The system builds and displays the report online.

6. Click the printer icon, if you wish a hard copy of this report.

7. Click File, then Exit to close this report and return to the Patient List window.

CONTENTS

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52

WORKINg WITH INDIVIDuAl REPORTS

Different Types of Reports that are Available

Key Patient Data Report

This option allows you to create a tabular report, Key Patient Data, listing key pieces of information taken from the 24-Hour Collection records for individual patients.

Report Headings include:

• Patient Identifiers

• Collection Date

• Modality

• Total CrCl

• Total Kt/V

• Fluid Removal

To create this report, follow these steps:

1. Click to highlight the patient record from the Patient List.

2. Click to highlight the Collection Date record located in the lower portion of the screen.

3. From the PD Adequest Main Menu toolbar, click Individual Reports.

4. Click Key Patient Data.

5. The system builds and displays the report online.

6. Click the printer icon, if you wish a hard copy of this report.

7. Click File, then Exit to close this report and return to the Patient List window.

• Est. GRF

• Serum Albumin

• nPCR

• BSA

• Est Body Water

• Transport Type

CONTENTS

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53

WORKINg WITH INDIVIDuAl REPORTS

Different Types of Reports that are Available

Individual graphs

There are also a variety of graphs available in PD Adequest. This can be useful with analysing trends over time for a particular patient.

To access an individual graph, highlight a patient and select graphs from the toolbar

CONTENTS

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54

WORKINg WITH INDIVIDuAl REPORTS

PET Curves

Adult PET Curves Individual graph

PET curves are different from trends in that they display information taken at one point in time only. These curves are intended to give you the ability to view the results of the Peritoneal Equilibration Test (PET) in a graphical manner.

Note: A patient is classified as an adult if he/she is > 16 years of age.

Graph Description - – The patient’s curve is plotted on a template to visually evaluate the patient’s membrane transport category. These categories include:

• High - Red

• High Average - Blue

• Low Average - Yellow

• Low – Green

You can view the PET curves for Creatinine, Urea and Glucose by selecting the corresponding tab at the top of the page.

CONTENTS

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WORKINg WITH INDIVIDuAl REPORTS

PET Curves

Working with Individual Reports

To create the Adult PET Curves graph, follow these steps:

1. Click to highlight the patient record from the Patient List.

2. From the PD Adequest main menu toolbar, click graphs.

3. Click Adult PET Curves.

4. The system builds and displays the report online.

5. Click Print Preview.

6. Modify the design as described above.

7. At completion, click Print.

8. Click Close to close the Print Preview window.

9. Click Close to close this report and return to the Patient List window.

CONTENTS

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60

gETTINg STARTED

DRAFT

Population Selection

Customising and Setting Targets

QA Reports

Group Reports

Group Graphs

gROuP REPORTS - CONTINuOuS quAlITy IMPROVEMENT

CONTENTS

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gROuP REPORTS - CONTINuOuS quAlITy IMPROVEMENT

Population Selection

The group Reporting Module

PD Adequest uses a wide variety of reports and graphs to identify patients falling below adequacy targets. The group report feature allows you to identify the patients’ who may be in need of a prescription change. You are able to pro-actively make adjustments to these patients prescriptions so they are able to maintain and prolong their PD therapy.

The program allows users to perform detailed database searches with just the click of a mouse. It is easy to specify a certain group of patients for analysis based on specified criteria.

Specify the criteria for your search then click the search button to retrieve a custom list of these patients. (You can review your search results under the “Search Results” tab).

Tip: you must click search to perform group reporting on the selected group of patients.

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gROuP REPORTS - CONTINuOuS quAlITy IMPROVEMENT

Customizing and Setting Targets

Once a group of patients has been selected, users can easily identify the patients falling below adequacy targets through the qA Report function and refer back to the Regimen and Optimization modules to evaluate alternative regimens that may improve patient clearances.

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gROuP REPORTS - CONTINuOuS quAlITy IMPROVEMENT

QA Reports

using PD Adequest for Continuous quality Improvement

To assist with achieving your unit’s clinical adequacy targets, you can customize your clinical targets under the default system values menu.

This window is found in the Menu bar under System-Defaults.

These setting’s will determine the targets for the PD Adequest Group QA reports window.

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QA Reports

The PD Adequest Group QA reports can help you identify patients that may need special attention based on the targets you have set in the default system values window.

What are your units Targets? Insert them into the right hand column:

Parameter your units Targets

Kt/V <_________

Creatinine Clearance <______L/week/1.73m2

Serum Albumin <_____g/L

nPCR <____ g/kg/day

24 Hour Fluid Removal <____ L/day

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gROuP REPORTS - CONTINuOuS quAlITy IMPROVEMENT

QA Reports

Example of a QA Report

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gROuP REPORTS - CONTINuOuS quAlITy IMPROVEMENT

Group Reports

An example of Key Patient Data Report

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gROuP REPORTS - CONTINuOuS quAlITy IMPROVEMENT

Group Graphs

Group Graphs will provide various graphs depending on your selected criteria.

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6868

Creatinine Correction Factor

Expiry Dates

ClINICAl VAlIDATION OF PD ADEquEST

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Creatinine Correction Factor

When measuring creatinine in the effluent, the high dextrose concentration of the peritoneal dialysis solution may interfere with an accurate creatinine measurement. The amount of interference depends on the assay and equipment used. Most laboratories use methodologies that utilize some form of the Jaffe reaction to measure creatinine. This assay is influenced by glucose, resulting in a falsely elevated creatinine measurement.

Some laboratories may correct for this interference when the solution contains up to 800 mg/dL glucose, but when using a 2.5% peritoneal dialysate solution the dextrose concentration is much higher. It is important to check with your laboratory personnel to determine their creatinine measurement accuracy when high dextrose-content solutions are used.

For an easy check, have creatinine and glucose measured in an aliquot of fresh 2.5% dextrose solution. Technically, there should be no creatinine in the sample (because it was from a fresh bag). Any creatinine value greater than zero indicates that a correction factor is needed to correct for the falsely elevated creatinine level. Divide the measured creatinine by the measured glucose to determine your correction factor.

This ratio provides an approximate adjustment, which assumes a linear relationship between the dialysate glucose level and the extent of the false elevation in creatinine. Omitting this adjustment will result in a modest error (of about 6%) in the D/P creatinine ratio after a four-hour dwell. However, when using shorter dwell exchanges, the dextrose concentration is much higher and the error may approach as much as 39% for a 30 minute dwell. Therefore, when utilizing PD Adequest we recommend determining the creatinine correction factor for your laboratory assays.

CONTENTSCONTENTS

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Clinical Validation of PD Adequest

A broad-based clinical study was completed in 1998 with the purpose of clinically validating the use of the PD ADEQUEST 2.0 computer kinetic model. This validation, carried out by the PD ADEQUEST International Study Group following a protocol developed by Baxter Healthcare, assessed the level of agreement between measured and predicted values of urea Kt/V, creatinine clearance (CrCl/week/1.73m2), glucose absorption (GA g/day) and ultrafiltration (UF/L) for both CAPD and APD prescriptions. This was an international, multicenter study of 104 adult PD patients (41 CAPD, 63 APD) in 16 centres. Measured (M) and predicted (P) values of Kt/V, CrCl, GA and UF were compared using correlations (r), concordance correlations (rc) and Bland-Altman limits of agreement. Measured values were obtained from three repeat 24 hour urine and dialysate collections while predicted values were independently modelled using the Baxter PD ADEQUEST 2.0 programme in combination with patient-specific parameters estimated from a 4 hour peritoneal equilibration test (PET) and long-dwell exchange.

Overall results indicate PD ADEQUEST 2.0 can predict Kt/V, Ccr, and GA with reasonable accuracy. For CAPD there was good agreement between predicted and measured UF values, and moderate agreement between predicted and measured UF values for APD.

Data Collection and Methods of Analysis

PD Adequest predictions were validated by comparing the measured results of the 24 hour collections with the predicted results from the PD Adequest model. Statistical comparisons between measured and predicted values were made using correlations, concordance correlations and Bland-Altman limits of agreement.

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Validation of Solute Removal Predictions

One of the primary goals of PD Adequest is to predict the amount of creatinine and urea removed from a patient’s blood during peritoneal dialysis treatment. While this removal can be described in different ways, the most basic is removal of grams of solute per day.

Initially, the model and analytical solutions described by Vonesh et al. together with methods for estimating individual patient parameters were scientifically assessed for their accuracy in predicting clearance and ultrafiltration. For each of five patients, dialysate volumes, as well as blood and dialysate concentrations for creatinine, urea, glucose, and b2-microglobulin, were measured over a six-hour dwell on each of two days. Each exchange was performed using a nominal two-litre solution containing 2.5% dextrose. The dialysate volumes were measured from tracer dilution and were corrected for lymphatic drainage and sampling volume. Modelled volumes and concentration profiles were calculated from equations described by Vonesh et al. The modelled values were then compared to the measured concentrations and volumes.

A concordance correlation coefficient was calculated to determine how closely the modelled values agree with actual measured values. The smallest concordance correlation was 0.984. Vonesh & Rippe obtained nearly identical correlations when the model was modified using the three-pore reflection coefficients. These results suggest that on a scientific basis, both concentration and volume profiles in peritoneal dialysis can be predicted extremely accurately using the methods employed by PD Adequest.

For further information on the scientific and clinical validation of PD Adequest, please refer to the help menu.

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Expiry Dates

ClINICAl VAlIDATION OF PD ADEquEST

PD Adequest Expiry Dates

When you install PD Adequest, a default expiration date will be set during the installations by adding six months to the date of installation. After the application is installed, a Baxter employee will re-set the expiration date according to your contract agreement with Baxter Renal.

To view your expiration date, follow these steps:

1. From the PD Adequest Main Menu, click Help.

2. Click About PD Adequest.

3. The About PD Adequest window is displayed.

4. The expiration date can be viewed from this window. It is located under the PD Adequest logo.

Note: When 90 days or less are remaining to the expiration date, the following message will be displayed: X days remaining for software license. Please contact your Baxter representative.

When your software expires, you will not be able to use the application. The message PD Adequest has expired on X. Please contact your Baxter representative.

Your Baxter representative will back up the database and reset your expiration date.

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Patient Pathway to First Prescription

Body Size

Residual Renal Function

Peritoneal Membrane Transport Type

gETTINg STARTED

Section 3

glOSSARy

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GlossaryGlossary

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Note: This glossary can also be found in the Help menu of PD Adequest

Adequacy

Determining if patient is receiving enough dialysis (dialysis effectiveness and nutritional status) to prevent uremic symptoms, e.g. weight loss, poor appetite, nausea.

Albumin loss

The amount of albumin lost from the body through diffusion across the peritoneal membrane into the peritoneal cavity. Since the Mass Transfer Area Coefficient (MTAC) of urea, creatinine and glucose are calculated from known laboratory data, the MTAC of albumin can be estimated based on molecular weight of albumin. This factor is then used with mass transfer equations to obtain albumin loss. Reference: Albumin Loss Predictions.

APD

Automated Peritoneal Dialysis. A type of peritoneal dialysis involving the internal peritoneal membrane in which exchanges are performed by a machine. Treatment parameters, such as the amount of solution to be infused and the length of time the solution remains in the peritoneal cavity, are programmed on the machine. The machine then automatically performs the treatment. In APD, you can modify the treatment parameters to meet the patient’s needs. Note: This was called CCPD in previous versions of PD Adequest.

Average Percent Dextrose

The percent of dextrose used during the full, daily PD regimen. Calculated as: (the sum of all PD solution dextrose concentrations in each container) x (the fill volume of each container) / (total fill volume).

BSA

Body Surface Area. Reference Body Surface Area Calculations .

BuN/Blood urea Nitrogen

A waste product of digested protein normally filtered out by the kidneys and excreted from the body in urine. Blood urea nitrogen accumulates in the blood. If SI units are selected, this is called Urea. If Metric units are selected, this is called BUN.

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CAPD

Continuous Ambulatory Peritoneal Dialysis; A type of dialysis in which the patient is free to move around, unconnected to a stationary machine. Exchanges are performed manually three to five times a day with dwell periods of four to six hours during the daytime and up to eight hours overnight. Dialysis takes place through the peritoneal membrane continuously, seven days a week, 24 hours a day.

CCPD

Continuous Cycling Peritoneal Dialysis; A continuous therapy in which a machine performs exchanges while a patient sleeps. The solution can be left in the cavity during the daytime, called CCPD with a wet day, or it can be completely drained before ending the treatment to leave the cavity empty during the daytime called CCPD with a dry day or NIPD (Nightly Intermittent Peritoneal Dialysis). Note: This is called APD in PD ADEQUEST.

Clearance

The volume of plasma that can be cleared of a specific solute by the kidneys per unit of time, expressed in ml/min. Clearance of a specific substance from the plasma depends on several factors: If a substance is filtered at the glomerulus and is not reabsorbed or secreted in the tubule, then clearance of that substance equals the amount filtered. If a substance is filtered at the glomerulus and partially or completely reabsorbed from the tubule, then clearance of that substance equals the amount filtered minus the amount reabsorbed. If a substance filtered at the glomerulus and secreted into the tubule, then clearance of that substance equals the amount filtered plus the amount secreted. If a substance is filtered at the glomerulus and both reabsorbed and secreted in the tubule, the clearance of that substance equals the amount filtered minus the amount reabsorbed plus the amount secreted. The amount cleared may be less than, equal to, or greater than the amount filtered depending on the rates of filtration, reabsorption, and secretion.

Clinical Objectives

The goals set by the clinician that define the desired target solute (either urea or creatinine), the desired amount of clearance (in litres per day), and the desired amount of ultrafiltration.

Creatinine Blood Concentration

The concentration of creatinine in the bloodstream while the selected PD regimen is dwelling. Calculated during both the daytime and the night-time exchanges. Calculated as (starting creatinine concentration + creatinine generation) – (creatinine removed).

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glOSSARy

Creatinine Clearance

The amount of blood that is cleared of creatinine in a given time period. Once creatinine is filtered through the glomerular capillaries, it passes through the nephron with minimal change and is excreted; hence creatinine clearance is a measure of the glomerular filtration rate. Creatinine clearance is an excellent clinical indicator of renal function; as renal function diminishes, creatinine clearance decreases.

Creatinine generation Rate

The concentration of creatinine the body produces in a given time period. Assuming the patient is in steady state, creatinine generation is equal to creatinine appearance. Reference: Creatinine Generation Rate Calculations.

Creatinine Clearance - Cumulative Cleared

The total litres of creatinine clearance obtained during a specific time period (e.g. during the day or during the night).

DAPD

Daytime Ambulatory Peritoneal Dialysis – DAPD is similar to CAPD, with the exception that the peritoneal cavity is left empty (dry) during the night.

Dialysate

The solution used in dialysis to draw waste product and excess water out of the blood.

Dianeal

Prescribed peritoneal dialysis solution used for intraperitoneal administration.

Diffusion

The movement of particles from an area of higher to an area of lesser concentration; diffusion ceases when equilibrium of particle concentration occurs. Diffusion does not use energy in the form of Adenosine triphosphate (ATP).

DPI

Dietary Protein Intake. Note: This is now called nPCR Note: DOQI Guideline 28 calls this PNA and nPNA.

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Estimated glomerular Filtration Rate

A factor used to describe the amount of urea clearance via dialysis and residual renal function, calculated as a weekly value. Reference: Estimated GFR Calculations.

Estimated Total Body Water

The estimated total body water is calculated using either the Hume & Weyers or the Watson & Watson method for patients age 17 or older or the Friis-Hansen method for paediatric patients (under age 17).

Extraneal (Icodextrin)

Extraneal is a peritoneal dialysis solution that uses a 7.5% polyglucose concentration as an osmotic agent instead of dextrose or glucose.

Fluid Absorption

The amount of fluid that passes from the peritoneal cavity into the bloodstream including lymphatic absorption. This value is calculated by iteratively examining the overnight and PET drain volumes. The model selects that value which most closely matches both recorded drain volumes.

gFR

The glomerular filtration rate is the volume of plasma filtered from the glomerular capillaries into Bowman’s capsule each minute.

glucose Absorbed – kcal

The number of kilocalories of glucose absorbed over 24 hours of a particular PD regimen. Calculated as (glucose absorbed in grams) x (3.72).

Hematocrit

Hct – The percentage of the volume of a blood sample occupied by cells.

High Dose/Optimized Continuous Peritoneal Dialysis (OCPD)

This is a form of APD therapy which is similar to CCPD, with the exception that one or more automated exchanges are made during the day. In this case, the patient connects to the HomeChoice device to drain and fill, and then disconnects from the device. A variant of High Dose/OCPD would involve the use of manual CAPD exchanges rather than automated exchanges during the day.

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Hydraulic Permeability

A factor that describes the permeability of the peritoneal membrane for fluid. This factor is calculated based upon comparison of the overnight drain volume and the four hour PET drain volume. It is physiologically impossible to have a negative hydraulic permeability value.

Icodextrin (Extraneal)

Icodextrin is a peritoneal dialysis solution that uses a 7.5% polyglucose concentration as an osmotic agent instead of dextrose or glucose.

Ideal Body Weight

Normalized Protein Catabolic Rate (nPCR) is a commonly accepted measure of nutritional status for dialysis patients. The Ideal Body Weight Window gives you the opportunity; to select an ideal body weight for normalization of PCR. The ideal body weight is chosen by the user, and is not suggested by PD ADEQUEST in any way. Note: Choosing an ideal body weight should not replace the patient’s actual body weight in the database, and should not have any effect on anything other than nPCR.

Intraperitoneal

A route of infusing medication or fluids into the peritoneal cavity.

K+ Potassium.

An important blood chemistry which may become elevated in ESRD patients and must be carefully monitored, as it effects the heart. Normal range is 3.5 – 5.5mEq/L.

Kinetics

The study of the rates of change of a system.

Kt/V

Urea removal calculated by time. K = urea clearance T = treatment time V = volume of total body water space.

Kt/V urea – Daily

The amount of urea clearance via dialysis and residual renal function during a 24-hour period.

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lymphatic Drainage

The amount of fluid that passes from the peritoneal cavity into the bloodstream via the lymphatic system. This value is calculated by iteratively examining the overnight and PET drain volumes. The model selects that value which most closely matches both recorded drain volumes. Note: This is now called Fluid Absorption.

Modality

A form of therapeutic regimen. PD ADEQUEST 2.0 contains the following modality options: CAPD, CCPD, DAPD, NIPD, Tidal PD High Doses/OCPD – APD with a Day Exchange Other/Unknown

MTAC

The Mass Transfer Area Coefficient is essentially the speed at which molecules move across a patient’s peritoneal membrane. The MTACs are essential components of the predictive modelling done by PD ADEQUEST, and are derived through the use of the PET.

Nephron

The filtering unit of the kidney

NIPD

Nightly Intermittent Peritoneal Dialysis is a continuous therapy in which a machine performs exchanges while a patient sleeps. The cavity is completely drained before ending the treatment and remains empty during the daytime. Note: Also referenced as APD (CCPD) with a dry day.

nPCR

Normalized Protein Catabolic Rate. nPCR when normalized to body weight is referred to as nPCR. This quantity represents protein intake as: (grams of protein / Kg body weight) / day. Note: This was formerly known as DPI (Dietary Protein Intake) DOQI Guideline 28 calls this PNA and nPNA. Reference: Protein Catabolic Rate Calculations.

Osmosis

The movement of water across a semi permeable membrane from an area of lower concentration of solutes to an area of higher concentration of solutes; osmosis ceases when concentration on the two sides of the semi permeable membrane equilibrates.

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PET

The standardized Peritoneal Equilibration Test developed by Dr. Zbylut Twardowski defines the peritoneal membrane’s clearance and ultrafiltration rates by measuring dialysate to plasma ratios of creatinine and glucose under specific conditions. This test is used to select a more accurate PD regimen to optimize dialysis based upon other parameters such as patient volume (weight), fluid or food consumption, and urea generation rate. Usually are of a four-hour duration. A four-hour PET, along with an overnight exchange, can be used as input into a kinetic to predict approximate clearance and Ultrafiltration. Reference Understand Actual Versus Simulated PETs .

Percent Ideal Weight

The Actual Weight / Ideal Body Weight expressed as a percentage.

Peritoneal Cavity

Abdominal cavity in the body where organs like the stomach, liver intestines and spleen are located. It is where peritoneal dialysis takes place.

Protein Catabolic Rate (PCR)

The rate at which protein is broken down into waste products during the normal body functions.

quANTuM PD

QUANTUM PD is a peritoneal dialysis system that utilizes a device to perform one automated exchange during the night. This system is now obsolete in Australia, Canada and New Zealand references in PD adequest should be ignored.

Residual Dialysate Volume

The amount of fluid that remains in the peritoneal cavity after a full drain. This factor is estimated from the overnight exchange solute concentrations and the zero hour PET concentrations and infusion volume.

Residual Renal Clearance – urea

The rate of renal clearance generated by the patient.

Serum Albumin

A protein found in the blood which is commonly used as a marker for nutritional status.

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Glossary

Serum Creatinine Concentration - Steady State

The concentration of creatinine in the patient’s bloodstream after two weeks of therapy using the prescribed PD regimen.

Serum urea Concentration - Steady State

The concentration of urea in the patient’s bloodstream after two weeks of therapy using the prescribed PD regimen.

Solute

A substance dissolved in a solution.

Target Creatinine Clearance

The desired rate of creatinine clearance to be used in selecting a desired regimen.

Target ultrafiltration

The desired volume of dialysate ultrafiltration to be used in selecting a desired regimen. Note: Target ultrafiltration refers only to dialysate ultrafiltration. Urinary fluid removal is not included.

Target BuN/urea Clearance

The desired rate of BUN/urea clearance to be used in selecting a desired regimen. Reference: Update Target BUN/Urea Clearance Calculations .

TDP / Tidal PD

Tidal Peritoneal Dialysis is a type of PD therapy where only a portion of the solution in the cavity is drained and replaced with fresh solution in each cycle of the therapy. Tidal PD can be performed on a continuous or intermittent basis.

ugR

Urea Generation Rate. The amount of urea the body makes in a given time period. Reference: Urea Generation Rate Calculation.

ultrafiltration

Removing of fluids through a membrane by exerting greater pressure on one side of the membrane.

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ultrafiltration Total

That net volume of fluid that is removed from the patient’s bloodstream through peritoneal dialysis.

urea

A waste product of digested protein normally filtered out by the kidneys and excreted from the body in urine. If SI units are selected, this is called Urea. If Metric units are selected, this is called BUN.

urea Kt/V

A factor used to describe the amount of urea clearance via dialysis and residual renal function. Reference: Urea Kt/V Target Calculation.

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Patient Pathway to First Prescription

Body Size

Residual Renal Function

Peritoneal Membrane Transport Type

gETTINg STARTED

Section 4

APPENDIx

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Appendix

APPENDIx 1

APPENDIx 15

International Clinical Practice guidelines Recommendations

NR = No consistency on the recommendations of the UF targets

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APPENDIx 2

Appendix

Body Surface Area

Body Surface Area affects the amount of dialysis a patient requires. Generally, larger patients require a larger dose of dialysis. The table below can be used to determine the patient’s BSA (m2).

Calculated by the formula: Body Surface Area = 0.007184 x (Patient’s Height, cm)0.725 x (Patient’s Weight, kg)0.425

DuBois D, DuBois EF. A Formula to Estimate the Approximate Surface Area if Height and Weight Be Known. Arch lntem Med. 17: 863-871. 1916

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Appendix

APPENDIx 3

A simple method for determining the volume of urea distribution is to estimate the patient’s total body water (TBW). It is important to note that different equations exist for estimating total body water, and using a different equation may give different values. The anthropometric volume of distribution of urea may be calculated by one of the following formulas based on age, height, weight and gender. These are derived from estimates of total body water in healthy subjects.

The following tables utilize the Watson and Watson formula and were developed and have been calculated for males of three different ages and for females. Only one table is used for females because age has no effect on the equation.34

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Appendix

APPENDIx 4

Volume of urea Distribution: 35-year-Old Male*

*For every 10-year increase in age, decrease volume by 1L for males.For every 10-year decrease in age, increase volume by 1L for males.

V<34L (small) V 34-41L (medium) V>41L (large)

V<34L (small) V 34-41L (medium) V>41L (large)

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Appendix

APPENDIx 5

Volume of urea Distribution: 55-year-Old Male*

*For every 10-year increase in age, decrease volume by 1L for males. For every 10-year decrease in age, increase volume by 1L for males.

V<34L (small) V 34-41L (medium) V>41L (large)

V<34L (small) V 34-41L (medium) V>41L (large)

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Appendix

APPENDIx 6

Volume of urea Distribution: 75-year-Old Male*

*For every 10-year increase in age, decrease volume by 1L for males. For every 10-year decrease in age, increase volume by 1L for males.

V<34L (small) V 34-41L (medium) V>41L (large)

V<34L (small) V 34-41L (medium) V>41L (large)

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Appendix

APPENDIx 7

120

19.6

20.1

20.6

21.1

21.6

22.1

22.6

23.1

23.6

24.0

24.5

25.0

25.5

26.0

26.5

27.0

27.5

28.0

28.5

29.0

29.5

30.0

30.5

31.0

31.4

31.9

32.4

32.9

33.4

33.9

34.4

34.9

35.4

35.9

36.4

36.9

37.4

37.9

38.4

38.8

125

20.1

20.6

21.1

21.6

22.1

22.6

23.1

23.6

24.1

24.6

25.1

25.6

26.1

26.6

27.0

27.5

28.0

28.5

29.0

29.5

30.0

30.5

31.0

31.5

32.0

32.5

33.0

33.5

34.0

34.4

34.9

35.4

35.9

36.4

36.9

37.4

37.9

38.4

38.9

39.4

130

20.7

21.2

21.7

22.2

22.7

23.1

23.6

24.1

24.6

25.1

25.6

26.1

26.6

27.1

27.6

28.1

28.6

29.1

29.6

30.0

30.5

31.0

31.5

32.0

32.5

33.0

33.5

34.0

34.5

35.0

35.5

36.0

36.5

37.0

37.4

37.9

38.4

38.9

39.4

39.9

135

21.2

21.7

22.2

22.7

23.2

23.7

24.2

24.7

25.2

25.7

26.1

26.6

27.1

27.6

28.1

28.6

29.1

29.6

30.1

30.6

31.1

31.6

32.1

32.6

33.0

33.5

34.0

34.5

35.0

35.5

36.0

36.5

37.0

37.5

38.0

38.5

39.0

39.5

40.0

40.4

140

21.7

22.2

22.7

23.2

23.7

24.2

24.7

25.2

25.7

26.2

26.7

27.2

27.7

28.2

28.7

29.1

29.6

30.1

30.6

31.1

31.6

32.1

32.6

33.1

33.6

34.1

34.6

35.1

35.6

36.0

36.5

37.0

37.5

38.0

38.5

39.0

39.5

40.0

40.5

41.0

145

22.3

22.8

23.3

23.8

24.3

24.7

25.2

25.7

26.2

26.7

27.2

27.7

28.2

28.7

29.2

29.7

30.2

30.7

31.2

31.7

32.1

32.6

33.1

33.6

34.1

34.6

35.1

35.6

36.1

36.6

37.1

37.6

38.1

38.6

39.0

39.5

40.0

40.5

41.0

41.5

150

22.8

23.3

23.8

24.3

24.8

25.3

25.8

26.3

26.8

27.3

27.7

28.2

28.7

29.2

29.7

30.2

30.7

31.2

31.7

32.2

32.7

33.2

33.7

34.2

34.7

35.1

35.6

36.1

36.6

37.1

37.6

38.1

38.6

39.1

39.6

40.1

40.6

41.1

41.6

42.1

155

23.4

23.8

24.3

24.8

25.3

25.8

26.3

26.8

27.3

27.8

28.3

28.8

29.3

29.8

30.3

30.7

31.2

31.7

32.2

32.7

33.2

33.7

34.2

34.7

35.2

35.7

36.2

36.7

37.2

37.7

38.1

38.6

39.1

39.6

40.1

40.6

41.1

41.6

42.1

42.6

160

23.9

24.4

24.9

25.4

25.9

26.4

26.8

27.3

27.8

28.3

28.8

29.3

29.8

30.3

30.8

31.3

31.8

32.3

32.8

33.3

33.7

34.2

34.7

35.2

35.7

36.2

36.7

37.2

37.7

38.2

38.7

39.2

39.7

40.2

40.7

41.1

41.6

42.1

42.6

43.1

165

24.4

24.9

25.4

25.9

26.4

26.9

27.4

27.9

28.4

28.9

29.4

29.8

30.3

30.8

31.3

31.8

32.3

32.8

33.3

33.8

34.3

34.8

35.3

35.8

36.3

36.7

37.2

37.7

38.2

38.7

39.2

39.7

40.2

40.7

41.2

41.7

42.2

42.7

43.2

43.7

170

25.0

25.4

25.9

26.4

26.9

27.4

27.9

28.4

28.9

29.4

29.9

30.4

30.9

31.4

31.9

32.4

32.8

33.3

33.8

34.3

34.8

35.3

35.8

36.3

36.8

37.3

37.8

38.3

38.8

39.3

39.7

40.2

40.7

41.2

41.7

42.2

42.7

43.2

43.7

44.2

175

25.5

26.0

26.5

27.0

27.5

28.0

28.4

28.9

29.4

29.9

30.4

30.9

31.4

31.9

32.4

32.9

33.4

33.9

34.4

34.9

35.4

35.8

36.3

36.8

37.3

37.8

38.3

38.8

39.3

39.8

40.3

40.8

41.3

41.8

42.3

42.8

43.2

43.7

44.2

44.7

180

26.0

26.5

27.0

27.5

28.0

28.5

29.0

29.5

30.0

30.5

31.0

31.4

31.9

32.4

32.9

33.4

33.9

34.4

34.9

35.4

35.9

36.4

36.9

37.4

37.9

38.4

38.8

39.3

39.8

40.3

40.8

41.3

41.8

42.3

42.8

43.3

43.8

44.3

44.8

45.3

185

26.6

27.1

27.5

28.0

28.5

29.0

29.5

30.0

30.5

31.0

31.5

32.0

32.5

33.0

33.5

34.0

34.4

34.9

35.4

35.9

36.4

36.9

37.4

37.9

38.4

38.9

39.4

39.9

40.4

40.9

41.4

41.8

42.3

42.8

43.3

43.8

44.3

44.8

45.3

45.8

190

27.1

27.6

28.1

28.6

29.1

29.6

30.1

30.5

31.0

31.5

32.0

32.5

33.0

33.5

34.0

34.5

35.0

35.5

36.0

36.5

37.0

37.4

37.9

38.4

38.9

39.4

39.9

40.4

40.9

41.4

41.9

42.4

42.9

43.4

43.9

44.4

44.8

45.3

45.8

46.3

195

27.6

28.1

28.6

29.1

29.6

30.1

30.6

31.1

31.6

32.1

32.6

33.1

33.5

34.0

34.5

35.0

35.5

36.0

36.5

37.0

37.5

38.0

38.5

39.0

39.5

40.0

40.4

40.9

41.4

41.9

42.4

42.9

43.4

43.9

44.4

44.9

45.4

45.9

46.4

46.9

200

28.2

28.7

29.1

29.6

30.1

30.6

31.1

31.6

32.1

32.6

33.1

33.6

34.1

34.6

35.1

35.6

36.1

36.5

37.0

37.5

38.0

38.5

39.0

39.5

40.0

40.5

41.0

41.5

42.0

42.5

43.0

43.4

43.9

44.4

44.9

45.4

45.9

46.4

46.9

47.4

36

38

40

42

44

46

48

50

52

54

56

58

60

62

64

66

68

70

72

74

76

78

80

82

84

86

88

90

92

94

96

98

100

102

104

106

108

110

112

114

WEI

GH

T (KG

)

HEIGHT (CM)

120

19.6

20.1

20.6

21.1

21.6

22.1

22.6

23.1

23.6

24.0

24.5

25.0

25.5

26.0

26.5

27.0

27.5

28.0

28.5

29.0

29.5

30.0

30.5

31.0

31.4

31.9

32.4

32.9

33.4

33.9

34.4

34.9

35.4

35.9

36.4

36.9

37.4

37.9

38.4

38.8

125

20.1

20.6

21.1

21.6

22.1

22.6

23.1

23.6

24.1

24.6

25.1

25.6

26.1

26.6

27.0

27.5

28.0

28.5

29.0

29.5

30.0

30.5

31.0

31.5

32.0

32.5

33.0

33.5

34.0

34.4

34.9

35.4

35.9

36.4

36.9

37.4

37.9

38.4

38.9

39.4

130

20.7

21.2

21.7

22.2

22.7

23.1

23.6

24.1

24.6

25.1

25.6

26.1

26.6

27.1

27.6

28.1

28.6

29.1

29.6

30.0

30.5

31.0

31.5

32.0

32.5

33.0

33.5

34.0

34.5

35.0

35.5

36.0

36.5

37.0

37.4

37.9

38.4

38.9

39.4

39.9

135

21.2

21.7

22.2

22.7

23.2

23.7

24.2

24.7

25.2

25.7

26.1

26.6

27.1

27.6

28.1

28.6

29.1

29.6

30.1

30.6

31.1

31.6

32.1

32.6

33.0

33.5

34.0

34.5

35.0

35.5

36.0

36.5

37.0

37.5

38.0

38.5

39.0

39.5

40.0

40.4

140

21.7

22.2

22.7

23.2

23.7

24.2

24.7

25.2

25.7

26.2

26.7

27.2

27.7

28.2

28.7

29.1

29.6

30.1

30.6

31.1

31.6

32.1

32.6

33.1

33.6

34.1

34.6

35.1

35.6

36.0

36.5

37.0

37.5

38.0

38.5

39.0

39.5

40.0

40.5

41.0

145

22.3

22.8

23.3

23.8

24.3

24.7

25.2

25.7

26.2

26.7

27.2

27.7

28.2

28.7

29.2

29.7

30.2

30.7

31.2

31.7

32.1

32.6

33.1

33.6

34.1

34.6

35.1

35.6

36.1

36.6

37.1

37.6

38.1

38.6

39.0

39.5

40.0

40.5

41.0

41.5

150

22.8

23.3

23.8

24.3

24.8

25.3

25.8

26.3

26.8

27.3

27.7

28.2

28.7

29.2

29.7

30.2

30.7

31.2

31.7

32.2

32.7

33.2

33.7

34.2

34.7

35.1

35.6

36.1

36.6

37.1

37.6

38.1

38.6

39.1

39.6

40.1

40.6

41.1

41.6

42.1

155

23.4

23.8

24.3

24.8

25.3

25.8

26.3

26.8

27.3

27.8

28.3

28.8

29.3

29.8

30.3

30.7

31.2

31.7

32.2

32.7

33.2

33.7

34.2

34.7

35.2

35.7

36.2

36.7

37.2

37.7

38.1

38.6

39.1

39.6

40.1

40.6

41.1

41.6

42.1

42.6

160

23.9

24.4

24.9

25.4

25.9

26.4

26.8

27.3

27.8

28.3

28.8

29.3

29.8

30.3

30.8

31.3

31.8

32.3

32.8

33.3

33.7

34.2

34.7

35.2

35.7

36.2

36.7

37.2

37.7

38.2

38.7

39.2

39.7

40.2

40.7

41.1

41.6

42.1

42.6

43.1

165

24.4

24.9

25.4

25.9

26.4

26.9

27.4

27.9

28.4

28.9

29.4

29.8

30.3

30.8

31.3

31.8

32.3

32.8

33.3

33.8

34.3

34.8

35.3

35.8

36.3

36.7

37.2

37.7

38.2

38.7

39.2

39.7

40.2

40.7

41.2

41.7

42.2

42.7

43.2

43.7

170

25.0

25.4

25.9

26.4

26.9

27.4

27.9

28.4

28.9

29.4

29.9

30.4

30.9

31.4

31.9

32.4

32.8

33.3

33.8

34.3

34.8

35.3

35.8

36.3

36.8

37.3

37.8

38.3

38.8

39.3

39.7

40.2

40.7

41.2

41.7

42.2

42.7

43.2

43.7

44.2

175

25.5

26.0

26.5

27.0

27.5

28.0

28.4

28.9

29.4

29.9

30.4

30.9

31.4

31.9

32.4

32.9

33.4

33.9

34.4

34.9

35.4

35.8

36.3

36.8

37.3

37.8

38.3

38.8

39.3

39.8

40.3

40.8

41.3

41.8

42.3

42.8

43.2

43.7

44.2

44.7

180

26.0

26.5

27.0

27.5

28.0

28.5

29.0

29.5

30.0

30.5

31.0

31.4

31.9

32.4

32.9

33.4

33.9

34.4

34.9

35.4

35.9

36.4

36.9

37.4

37.9

38.4

38.8

39.3

39.8

40.3

40.8

41.3

41.8

42.3

42.8

43.3

43.8

44.3

44.8

45.3

185

26.6

27.1

27.5

28.0

28.5

29.0

29.5

30.0

30.5

31.0

31.5

32.0

32.5

33.0

33.5

34.0

34.4

34.9

35.4

35.9

36.4

36.9

37.4

37.9

38.4

38.9

39.4

39.9

40.4

40.9

41.4

41.8

42.3

42.8

43.3

43.8

44.3

44.8

45.3

45.8

190

27.1

27.6

28.1

28.6

29.1

29.6

30.1

30.5

31.0

31.5

32.0

32.5

33.0

33.5

34.0

34.5

35.0

35.5

36.0

36.5

37.0

37.4

37.9

38.4

38.9

39.4

39.9

40.4

40.9

41.4

41.9

42.4

42.9

43.4

43.9

44.4

44.8

45.3

45.8

46.3

195

27.6

28.1

28.6

29.1

29.6

30.1

30.6

31.1

31.6

32.1

32.6

33.1

33.5

34.0

34.5

35.0

35.5

36.0

36.5

37.0

37.5

38.0

38.5

39.0

39.5

40.0

40.4

40.9

41.4

41.9

42.4

42.9

43.4

43.9

44.4

44.9

45.4

45.9

46.4

46.9

200

28.2

28.7

29.1

29.6

30.1

30.6

31.1

31.6

32.1

32.6

33.1

33.6

34.1

34.6

35.1

35.6

36.1

36.5

37.0

37.5

38.0

38.5

39.0

39.5

40.0

40.5

41.0

41.5

42.0

42.5

43.0

43.4

43.9

44.4

44.9

45.4

45.9

46.4

46.9

47.4

36

38

40

42

44

46

48

50

52

54

56

58

60

62

64

66

68

70

72

74

76

78

80

82

84

86

88

90

92

94

96

98

100

102

104

106

108

110

112

114

WEI

GH

T(KG

)

HEIGHT(CM)

Volume of urea Distribution: Female

CONTENTS

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87

Appendix

APPENDIx 9

Peritoneal Equilibration Test Procedure19, 26, 47

Weigh and infuse 2l bag 2.5% dextrose

0 hours & analysed for creatinine, glucose

(urea if using PD Adequest)

2 hours & analysed for creatinine, glucose

(urea if using PD Adequest)

A serum sample is taken after 2 hours & analysed

for analysed for creatinine, glucose (Also urea if using

PD Adequest)

4 hours & analysed for creatinine, glucose

(urea if using PD Adequest)

Weigh and infuse 2l bag 4.25% dextrose

Dialysate samples are taken after:

After a 4 hour dwell, the dialysate is drainedWeigh bag to determine ultrafiltration

Based on measured results, the patient’s D/P for creatinine and D/Do are calculated

The patient’s 4 hour D/P will classify the patient as:

High High average Low average Low transport type

OR

Assessing Peritoneal Equilibration Test (PET) 4 hours

• Prescription management software may require serum andperitoneal dialysate urea measurement.

• If non-enzymatic method (i.e picric acid assay) is used for analysisof creatinine, be sure to use correction factor to accuratelyestimate creatinine value.

CONTENTS

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88

Appendix

APPENDIx 10

Modified Peritoneal Equilibration Test Procedure 26,47

This approach allows for the determination of sodium sieving by profiling the changes in dialysate Na+ concentration induced by osmotically driven water flow. Because water influx into the peritoneal cavity is mediated by aquaporins, the enhanced osmotic drive will draw water into the peritoneal cavity, thereby diluting the Na+ concentration. The greater the influx of water via aquaporins, the greater the decline in dialysate Na+ observed in the 1 hour sodium sample. Measurement of Na+ sieving will allow better diagnostic discrimination of the causes of impaired UF.26

0 hours & analysed for creatinine, glucose

& sodium

1 hours to measure sodium to assess

sodium sieving

2 hour dwell: blood samples analysed for creatinine, glucose

& sodium

2 hours & analysed for creatinine,

glucose & sodium

4 hours & analysed for creatinine,

glucose & sodium

Weigh and infuse 4.25% glucose

Dialysate samples are taken at:

After a 4 hour dwell, the dialysate is drainedand the total volume measured

Based on measured results, the patient’s D/P for creatinine and D/Do are calculated

The patient’s 4 hour D/P will classify the patient as:

High High average Low average Low transport type

CONTENTS

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89

Appendix

APPENDIx 11

APD Regimens (Examples)

A variety of APD regimes are possible depending upon whether the patient is prescribed PD fluid during the day (wet versus dry) and the number and length of daytime dwells.

Particular advantages are:

1. NIPD - Nocturnal Intermittent Peritoneal Dialysis: empty peritoneal cavity during the day (“dry day”)- can be useful at the start of PD when there is significant residual renal function or in patientswith a leak or hernia.

2. Tidal PD - partial drain and fills during the night cycles - is particularly useful for patients with painat the end of the drain phase or in those with mechanical catheter problems.

3. High Dose PD - one of more extra day exchanges - can be used for patients requiring anincrease in peritoneal small solute clearance e.g. anuric patients, or very large patients.

APD Regimens (Examples)*

CAPD Regimen

CONTENTS

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90

Appendix

APPENDIx 12

Patient Daily Records - APD Treatment Records

Patient Daily Records - CAPD Treatment Records

CONTENTS

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91

Appendix

APPENDIx 13

Assumptions on Which Modelling Is Based

Data from 1,006 randomly selected adult PD patients from 39 U.S. centers were analysed and used to group patients according to their peritoneal membrane transport characteristics and Vurea. Based on four PET classifications and three Vurea categories, modelling was performed on PD Adequest to obtain prescriptions that would meet or exceed minimum adequacy and UF goals.35

Clearance goals have been subject to multiple revisions. The following targets were used to generate the sample prescriptions provided in the following pages. The sample prescriptions must not be considered medical advice and are not a substitute for clinical judgement.35

• Minimal Delivered Weekly Clearance goal: Kt/V ≥ 1.7 3

• Continuous Therapy: Fluid in peritoneal cavity seven days/week35

• ultrafiltration: ≥ 1.0 L/day. Adjustment of dialysis solutions including dextrose and icodextrinto meet the patient’s UF requirement is necessary. UF plays an important role in obtainingclearance. Increasing or decreasing UF also impacts clearance 35

• Residual Renal Function: For patients with ≥ 2 mL/min of RRF, prescriptions are based onkidney urea clearance 35

• CAPD: 8-hour overnight exchange 35

• APD: 9-hour cycler time 35, 36

• A glucose-sparing strategy, using 1.5% and 2.5% dextrose solutions, was appliedin modelling. Under these modelling assumptions, use of 4.25% was therefore precluded.However, 4.25% dextrose solutions can be used in situations of fluid overload. 35

Please note: The following tables contain sample prescriptions based on patient categories. These are provided for informational purposes only and should not be considered medical advice nor should they be substituted for individual clinical judgement.

It is important that you obtain a 24-hour urine and dialysate collection so that the delivered dose is at your goal and adjust the prescription accordingly. If one were to model the prescription, there would be many other prescription options you may want to consider.

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Appendix

APPENDIx 14

Suggested Prescriptions for Patients with Residual Kidney urea Clearance <2 ml/min*37

Kinetic modelling was performed using PD Adequest to create the tables below. Recommended dialysis prescriptions are intended to achieve a desired Kt/Vurea. of 1.7 and a minimum ultrafiltration of 1000 mL/day. To illustrate that modelling can be designed around additional targeted objec tives, use of 4.25% dextrose was omitted in these examples to avoid excessive glucose exposure. Only PD solutions containing dextrose concentrations of 1.5% and 2.5% where used in the modelling process while additional prescriptions were created using icodextrin in the long dwell. An extra daytime exchange (in addition to the last bag fill) was also included in selected situations to help augment clearance and ultrafiltration results for motivated patients as needed. Nine hour overnight treatments periods were considered for the APD prescriptions.

Irrespective of modelling, clinical judgment must always be employed in order to create individualized prescriptions that meet patients’ specific urea clearance, ultrafiltration, medical and lifestyle needs.

• Lowerconcentrationsofdextrose and/or a fewernumber of exchanges thanindicated here may be neededto achieve total UF targetsand euvolemia in the setting ofsubstantial volume output bythe kidneys.

1.5%/2.5% dextrose dialysis solutions

2.5% dextrose dialysis solutions

Icodextrin used in the long dwell period

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Appendix

APPENDIx 15

Suggested Prescriptions for Patients with Residual Kidney urea Clearance ≥ 2 ml/min*37

Kinetic modelling was performed using PD Adequest to create the tables below. Recommended dialysis prescriptions are intended to achieve a desired Kt/Vurea. of 1.7 and a minimum ultrafiltration of 1000 mL/day. To illustrate that modelling can be designed around additional targeted objec tives, use of 4.25% dextrose was omitted in these examples to avoid excessive glucose exposure. Only PD solutions containing dextrose concentrations of 1.5% and 2.5% where used in the modelling process while additional prescriptions were created using icodextrin in the long dwell. An extra daytime exchange (in addition to the last bag fill) was also included in selected situations to help augment clearance and ultrafiltration results for motivated patients as needed. Nine hour overnight treatments periods were considered for the APD prescriptions.

Irrespective of modelling, clinical judgment must always be employed in order to create individualized prescriptions that meet patients’ specific urea clearance, ultrafiltration, medical and lifestyle needs.

• Lowerconcentrationsofdextrose and/or a fewernumber of exchangesthan indicated here maybe needed to achievetotal UF targets andeuvolamia in the setting ofsubstantial volume outputby the kidneys.

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