Evidenced-Based Sepsis Care at St Joseph’s Medical Center, Stockton.

Dr Kass MD MPH FACCP DAASM Dr Herrera DO Jacquie DeMellow RN MS CCRN Sarah Solberg RN MS CNS Michelle Romero RN BSN TNCC ENPC

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Learning Objectives

After this presentation participants will be able to

• Describe the processes that were put in place for early identification of a patient with Severe Sepsis.

• Describe the history and evolution of the Sepsis Team at St Josephs Hospital.

• Identify where we stand in improving early delivery of antibiotics and fluid resuscitation in Severe Sepsis.

• Discuss strategies in overcoming the challenges of the 6 Hour and 24 Hour Bundle

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Sepsis Death: Necrotizing Fasciitis

• Woman with history of IV drug abuse causing multiple necrotic abscesses of the legs and arms walked into the Emergency Room with complaint of flu-like symptoms. Labs were drawn in triage. After a 3.5 hour wait in the lobby, she was brought to a room because of a critically high white blood cell count (66,000) and discovered to be hypotensive (BP 82/42) with a pulse of 147. IV fluids and IV antibiotics were initiated and she was admitted to telemetry. Seven hours later, she coded and was transferred to the ICU where she coded again and expired. Cause of death was likely sepsis from necrotizing fasciitis.

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Sepsis Death: Necrotizing Fasciitis (6 hour window 22:25)

1557 Sign in (walked in)

1625 Triage: Flu like symptoms since last night: BP 95/55, pulse 102, resp 18, 97% RA, 4/5 abdominal pain

1721 Blood cultures drawn; Magnesium 2.9 H, Liver enzymes HH, troponin 0.65, creatinine 1.85 H, K+ 5.2 H, WBC 66.1, bands 16 H

1920 Lactic acid level drawn (6.3 HH)

1930 Roomed, BP 82/42 (MAP 55), pulse 147, 5/5 abdominal pain, alert and oriented x 4

1950 IV fluids started at wide open rate, morphine 4mg IVP,

Rocephin IV

2020 Foley catheter inserted, BP 101/58 (MAP 72), pulse 93, 95% on 2LNP, alert and oriented x 4, 5/5 pain

2110 BP 91/69 (MAP 76), pulse 94, 96% on 2LNP, 5/5 pain

2120 Blood gas drawn: pH 7.29

2200 BP 118/67 (MAP 84), pulse 86, 97% 2LNP, 5/5 pain: Dilaudid 1mg IV administered

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2250 Admit to Oncology: BP 96/74 (MAP 81), T 37, Resp 16, SpO2 94% RA

0055 Telephone admission orders included

IV NS @ 90/hr

CBC, chem. Panel in AM

Morphine 2mg IV prn pain

Wound care consult

0110 Telephone order sepsis protocol

0115 Hung IV NS at 90ml/hr

0145 Morphine 2mg IVP pain 10/10 and Ambien 10mg

0400 Morphine 2mg IVP pain 10/10

0600 Morphine 2mg IVP pain 10/10. Urine output 300ml in 8 hours, 1290ml IV input.

0620 Critical WBC 79k called to Nurse

Sepsis Death: Necrotizing Fasciitis (6 hour window 22:25)

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0645 Patient demanding her methadone now: given

0655 Patient states relief from pain, drowsy, pale, diaphoretic. ALOC yet still verbally responsive to verbal and tactile stimuli.

0657 RRT called, found patient unresponsive not breathing no pulses

0658 Code Blue called

0745 Patient transferred to ICU

0850 Admitting physician and intensivist at bedside, dobutamine and vasopressin ordered stat

0906 Central line inserted by intensivist, followed by left groin arterial line

0950 Daptomycin and Doripenem IV ordered

1036 CXR bilateral pulmonary edema (patient received 6 liters of IV NS between 0831 and 1050)

1125 Code blue called for PEA family decided to remove ventilator, patient pronounced

Sepsis Death: Necrotizing Fasciitis

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SJMC Sepsis Team

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• Systemic Inflammatory Response Syndrome: SIRS is widespread inflammatory response and is clinically recognized by the presence of two or more of following:

– Temperature >38ºC or <36ºC

– Heart rate >90 beats/min

– Respiratory rate >20 breaths/min or PaCO2 <32 mmHg

– WBC >12,000 cells/mm3, <4000 cells/mm3, or with >10 percent immature (band) forms

Definitions

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Definitions

•Sepsis- infection plus systemic manifestations of infection.

•Severe sepsis- sepsis plus sepsis induced organ dysfunction or tissue hypoperfusion

•Septic shock- sepsis induced hypotension persisting despite adequate fluid resuscitation.

• Levy MM, Fink MP, Marshall JC, et al: 2001 SCCM/ESICM/ACCP/ATS/SIS

International Sepsis Definitions Conference. Crit Care Med 2003; 31:1250–1256

• Bone RC, Balk RA, Cerra FB, et al, and members of the ACCP/SCCM Consensus Conference: Definitions for sepsis and organ failure and guidelines for the use of innovative therapies in sepsis. Chest 1992; 101:1644–1655 and Crit Care Med 1992; 20:864–874

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EARLY GOAL-DIRECTED THERAPY IN THE TREATMENT OF SEVERE SEPSIS AND SEPTIC SHOCK

• Randomly assigned patients with severe sepsis or septic shock to receive either six hours of early goal-directed therapy or standard therapy (as a control) before admission to the intensive care unit.

Rivers et al. NEJM 2001

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The Importance of Early Goal-Directed Therapy for Sepsis Induced Hypoperfusion

Adapted from Table 3, page 1374, with permission from Rivers E, Nguyen B, Havstad S, et al.

Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med

2001; 345:1368-1377. Surviving Sepsis Campaign

In-hospital mortality

(all patients)

0

10

20

30

40

50

60 Standard therapy

EGDT

28-day mortality

60-day mortality

NNT to prevent 1 event (death) = 6-8

Mo

rtality

(%

)

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EARLY GOAL-DIRECTED THERAPY IN THE TREATMENT OF SEVERE SEPSIS AND SEPTIC SHOCK

• During the interval from 7 to 72 hours, the patients assigned to early goal directed therapy had

– a significantly higher mean central venous oxygen saturation (70.4+/-10.7 percent vs. 65.3 +/-11.4 percent),

– a lower lactate concentration (3.0 +/-4.4 vs. 3.9+/-4.4 mmol per liter),

– a lower base deficit (2.0+/-6.6 vs. 5.1_/-6.7 mmol per liter),

– and a higher pH (7.40 +/-0.12 vs. 7.36 +/-0.12) than the patients assigned to control group.

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Conclusions

–Early goal-directed therapy provides significant benefits with respect to outcome in patients with severe sepsis and septic shock.

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Duration of hypotension before initiation of effective antimicrobial therapy is the critical determinant of survival in human septic shock Kumar et al. Crit Care Med 2006 Vol. 34. No. 6

–A retrospective cohort study

–Fourteen intensive care units

–Medical records of 2731 adult patients with septic shock

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Clinical Innovations Severe Sepsis Goals

By implementing nationally recognized evidence-based best practices,

CHW will reduce severe sepsis-related in-hospital mortality by 5%

and save $15 Million by June 30, 2010

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FY08 Goals for St. Joseph’s Stockton:

• FY08 mortality goal: Lower mortality rate by 30%

• FY08 cost reduction goal: Lower inflation adjusted direct variable cost by 5%.

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1) Deploy hospital-based Clinical Innovations Sepsis Teams with clinical leaders to focus on

sustained, improved sepsis outcomes using LEAN, Six Sigma and other process improvement methods

2) Identify severe sepsis and septic shock patients early and treat aggressively using the 2008 Surviving Sepsis Campaign Severe Sepsis Guidelines

• Educate physicians and nurses to recognize severe sepsis

• Leverage Rapid Response Teams

• Use technology (Cerner Sepsis Case Finders) to identify potential cases

3) Develop processes to support consistent implementation of the first four elements of the 6-hour Sepsis Bundle

4) Monitor compliance to the first four elements of the 6-hour sepsis bundle, provide physician-specific feedback and perform system wide benchmarking

5) Improve clinical documentation on severe sepsis patients

6) When needed, involve Palliative Care clinicians early to support the patient and family goals of care

Strategies to Achieve Severe Sepsis Goals

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3-Year CI Sepsis CHW System Results FY’07 – ‘10

•Mortality reduction = 58.2% (p <.05)

•Lives Saved = 1,153

•Cost reduction = $36.2M

•86% (N=32) Hospitals met both cost & mortality reduction goals

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3-Year CI Sepsis St Joseph’s Medical Center Results

Mortality reduction = 44%

•Lives Saved = 27

•Cost reduction = $1, 320,663

•We met both cost & mortality reduction goals

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Sepsis Health Grades Ratings

***Corresponds with project baseline***

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Phase One Order Set 2009

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Future Goals of the Sepsis Team FY ‘09

• Increased use of protocols by ED physician.

• Combine Phase I with Phase II to ensure continuity.

• Combining Blood Cultures with Serum Lactates

• Screening patient’s for Severe Sepsis whenever Blood Cultures are ordered.

• Identifying patients early before they get hypotensive.

• Use of the Oximetric Central Venous Catheter.

• Continue to review cases that fall out.

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Future Goals of the Sepsis Team FY ‘09

• Increased use of protocols by ED physician.

• Combine Phase I with Phase II to ensure continuity.

• Combining Blood Cultures with Serum Lactates

• Screening patient’s for Severe Sepsis whenever Blood Cultures are ordered.

• Identifying patients early before they get hypotensive.

• Use of the Oximetric Central Venous Catheter.

• Continue to review cases that fall out.

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Grand

Rounds Meditech

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Sepsis Order Set Used by ER MD

27%

91%

56%

75%

33%

68%

53%

0%

33%

50%

13%

0%

7%

49%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

SE

MR

78

SE

MR

03

SE

MR

22

SE

MR

08

SE

MR

75

SE

MR

80

SE

MR

06

SE

MR

79

SE

MR

07

SE

MR

52

SE

MR

46

SE

MR

71

SE

MR

69

Gra

nd

Tota

l

15 22 18 4 6 25 15 2 3 2 15 1 14 142

Cases Reviewed 2008 / Physician ID

% c

ases w

ith

sep

sis

ord

er

set

used

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Future Goals of the Sepsis Team FY ‘09

• Increased use of protocols by ED physician.

• Combine Phase I with Phase II to ensure continuity.

• Combining Blood Cultures with Serum Lactates

• Screening patient’s for Severe Sepsis whenever Blood Cultures are ordered.

• Identifying patients early before they get hypotensive.

• Use of the Oximetric Central Venous Catheter.

• Continue to review cases that fall out.

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Future Goals of the Sepsis Team FY ‘09 • Increased use of protocols by ED physician.

• Combine Phase I with Phase II to ensure continuity.

• Combining Blood Cultures with Serum Lactates

• Screening patient’s for Severe Sepsis whenever Blood Cultures are ordered.

• Identifying patients early before they get hypotensive.

• Use of the Oximetric Central Venous Catheter.

• Continue to review cases that fall out.

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MR#

Discharge

Committee Reason for Review

Date Assigned Results/Actions Taken

509945 10/4/09 ED

Pt is DNR. Consider surgical consult in am 1/4/10 Care appropriate.

345641 10/9/09 ED No sepsis order set 1/4/10 Care appropriate.

586780 10/23/09 ED Blood culture timing 1/4/10 Care appropriate.

92631 10/3/09 ED Abx timing. Comfort Care 1/4/10 Care appropriate.

122866 10/5/09 ED

Lactate w/in 6 hrs. Blood culture timing 1/4/10

203249 10/27/09 ED 1/4/10

Care appropriate. Remind Committee to use Sepsis Order Set

966993 10/7/09 ED ABX timing. 1/4/10 Mgmt controversial. No action needed

375785 10/30/09 ED Inadequate bolus in ED 1/4/10 Care appropriate.

45002 10/27/09 ED Lactate w/in 6 hrs 1/4/10

158024 10/23/09 ED Lactate w/in 6 hrs 1/4/10

Care appropriate. Remind Committee to use Sepsis Order Set

868647 11/11/09 ED Transfer to ICU vs. floor 1/4/10 Does not need ED Review

959708 11/14/09 Medicine

No fluid bolus. Abx timing. Comfort care 1/4/10

971052 11/25/09 ED

Lactate w/in 6 hrs. Abx timing 1/4/10

967915 11/3/09 ED No sepsis order set 1/4/10

267177 11/9/09 ED Fluid bolus inadequate 1/4/10 Care appropriate.

946808 11/18/09 Medicine 1/4/10

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70 yr old lady brought into ED for chills and rigors. She had a temp of 39 C and history of dry cough

• Vital Signs

– T – 39

– HR 111

– RR – 32

– BP 147/80 mmHg

– SpO2 100% on room air

• Labs WBC – 8 Hgb - 9.3

HCT - 29

Plts - 179

Na - 143

K - 4.3

Cl - 110

CO2 - 22

BUN – 39

Cr - 2.1

Lactate - 2.5

• CXR - ? RLL Pneumonia

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11:44 – Triage time (Sepsis screen +ve)

12:40 – Lactate drawn

12:40 – Blood Cultures drawn

12:49 – IV Ceftriaxone given

12:00 - 1Liter Normal Saline

15:00 - 1 Liter Normal Saline

• Patient discharged home with follow up to primary physician and with renal physician for Creatinine 2.1 – 2.5

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Milestones

•ICU and ED Physician champions.

•More aggressive fluid resuscitation.

•Steroids clarified.

•Lactate clearance.

•PICC Lines vs CVP lines.

•Eliminate Xigris.

•Sepsis Screening tool in Meditech.

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Existing processes in place

• Sepsis screening tool in ED, on admission data base, daily flow sheet and RRT form.

• Order Sets with bulleted items except for antibiotics.

• RRT Order Set - start Sepsis Protocol while waiting for physician confirmation -in patients that screen positive for Sepsis.

• If Sepsis Patient, PICC line top priority.

• Chart audits 20 per month and all RRT’s with Sepsis Presentation.

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Sepsis Drug Xigris Pulled From Worldwide Market Robert Lowes

Posted: 10/25/2011 October 25, 2011 — Eli Lilly is withdrawing activated

drotrecogin alfa (Xigris), a drug intended to treat severe sepsis in high-risk patients, from all markets including the United States in the wake of a new study showing that the agent did no better than a placebo in reducing mortality.

The European Medicines Agency (EMA), the European equivalent of the US Food and Drug Administration (FDA), announced today that the manufacturer had informed it of the decision to pull activated drotrecogin alfa from the market worldwide, as well as discontinue all ongoing clinical trials involving the drug.

The EMA stated that physicians should stop ongoing treatment of patients with activated drotrecogin alfa and should no longer start new patients on the agent — a warning repeated by the FDA today.

Activated drotrecogin alfa is a recombinant form of human activated protein C. The drug's efficacy has been questioned ever since the FDA authorized it for use here almost 10 years ago after a 20 to 20 vote by an agency advisory panel to recommend approval.

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The ED Story

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EMERGENCY DEPARTMENT

– Most of the hospital admissions for Sepsis begin here…..in the Emergency Dept.

– 70% of all hospital admissions come through the ED

– Early identification of sepsis patients is key to timely treatment and implementation of the important sepsis bundle

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Meditech Electronic Health Record

• Moved “Sepsis Screening Tool” up into top five nurse assessment on triage screen

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Nurse Education

• Importance of early Sepsis Screen on all patients who enter the ED

• Time goal: less than 30 minutes of arrival

• Often determined upon hearing pt. chief complaint & vital sign assessment

• Door to Vital Sign < 15 minutes

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Communication

• Nurse communication with provider when suspect sepsis for a patient.

• Provider in triage (PA) does initial Medical Screening Exam (MSE).

• Encouraged to initiate Phase One Sepsis Orders .

• Use color coded alert to place on top of patient’s chart while awaiting physician evaluation.

• Nurse request physician: “This patient has screened (+) for Sepsis. Would you like to start the Sepsis Order Set?”.

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Sepsis Flag

SUSPECT SEPSIS

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Blood Culture prior to Antibiotics

• Ongoing education about blood cultures prior to antibiotic administration

• Green dot placed on pt. armband by Lab after blood draw for blood culture

• Nurse confirms blood culture drawn

• Expedite antibiotics ASAP after blood cultures drawn

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Antibiotic Challenge

• Physician enters order for antibiotic into Med orders in Meditech

• Pharmacist must do initial review or antibiotic order and release med

• Nurse waits for med to be released, then returns to remove med from Omnicell

• Working with Pharmacy now on trying to get key antibiotic on override to expedite administration

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Proposed ED Triage Screen (in Test Mode)

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Secondary Sepsis Screen

• If patient screens (-) on initial Sepsis Screen, a secondary screen is done after pertinent lab results return

• “Sepsis Screen” shows up on patient Worklist with a reminder every 30 min. to click Lab results to review Labs & conduct Secondary Sepsis Screen

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Secondary Screen in ED

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Worklist Secondary Sepsis Screen

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Chart Audit

• Starting 11/11 an audit is being conducted on 20 ED patient charts/week to see if key assessments are being completed within prescribed time goals:

1. Door to Vital Signs < 15 minutes

2. Door to Sepsis Screen < 30 minutes

3. Door to Provider < 30 minutes

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ED Sepsis Screening < 30 min

N = 40 random audit

• Nov 2011 87%

• Dec. 2011 91%

• Jan. 2012 93%

• Feb 2012 98%

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What has worked?

• Moving Sepsis Screening Tool up to

“Top 5” for Triage Nursing Assessment

• Change in Triage Flow process with additional nurse for patient reception and plan for ‘surge’ to assess patients quickly

• Visual tools to alert provider for Sepsis

• Continued education with staff on need for early identification of potential sepsis patients and need to implement Sepsis Order set ASAP.

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Continued Improvement

• Meditech: Secondary Sepsis Screen added to patient worklist with continued reminders to check for lab results & conduct secondary screen

• Continue to incorporate elements of Sepsis Bundle in the Sepsis Panel order screen for physicians

• Sepsis Order set to print out on patients who screen (+) for sepsis

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The Work Goes On

• As with most process improvement in the hospital, key elements are:

• COMMUNICATION: Nurses, providers, physicians…TALK…SHARE….SUGGEST

• EDUCATION: Continue with nurse education regarding rapid assessment, early identification & sepsis bundle

• FEEDBACK: Let people know how we are doing, and what we can improve on!

Thank you!