Najmi Critical Appraisal

7/28/2019 Najmi Critical Appraisal

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Oleh : M NAJMI HABIBI09711213

Comparison between normal saline and a

polyelectrolyte solution for fluid resuscitation

in severely dehydrated infants with acute

diarrhoea


2/16

Judul jurnal : Comparison between normal

saline and a polyelectrolyte solution for fluid

resuscitation in severely dehydrated infants with

acute diarrhoea

Peneliti : Conceic A O A. Juca, Luis C. Rey &

Ceci V. Martins

Diterbitkan oleh : Annals of TropicalPaediatrics. Pada tahun 2005, volume 25,

halaman 253260.


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Sekitar 9% seluruh pasien di bawah usia 5 tahun di seluruh duniaadalah diare dan dehidrasi. Meskipun hanya 2-3% dari kasus diareakut menyebabkan dehidrasi berat atau syok, tapi keadaan tersebutadalah keadaan yang paling berbahaya yang terjadi pada 22% daribayi di bawah umur 1 tahun. Di timur laut Brazil, 43% dari semuaanak dengan usia < 4 tahun dirawat di rumah sakit dengan diare.

Angka morbiditas dan mortalitas yang disebabkan oleh kejadiandehidrasi pada diare telah menurun setelah efektifdiimplementasikan prosedur standar dalam terapi rehidrasikhususnya oral (ORT) yang promosikan oleh World HealthOrganization (WHO). Namun sampai saat ini pemberian cairanintravena untuk resusitasi cairan pada pasien dehidrasi masih dalam

perdebatan. Penelitian ini mengevaluasi pengaruh pertambahan volume,perubahan elektrolit dan ketidakseimbangan asam basa denganpemberian larutan polielektrolit yang dibandingkan dengan NS dipar-cepat enteral infus cairan pada bayi dengan dehidrasi berat.


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Penelitian ini adalah penelitian mengenai perbandingan dengan sampelyang diacak dan penelitian terbuka (pihak pasien mengetahui intervensiyang diberikan). Proses pengacakan dengan menyortir serangkaiansekuensial amplop yang berisi dua kelompok pengobatan cairan parenterallarutan NaCl 0,9% dan PS (sesuai dengan rumus). Hasil utama yang diukuradalah durasi dan volume rehidrasi yang dibutuhkan untuk mengoreksi

dehidrasi. Sedangkan hasil sekunder yang dinilai adalah tingkat plasma Na,K, Cl, dan urea kreatinin, pH arteri dan kadar bikarbonat. Kriteria inklusi dalam penelitian ini adalah pasien yang terdaftar di Unit

Darurat Rumah Sakit Infantil Albert Sabin, Fortaleza, Ceara, Brasil, belummenerima terapi cairan parenteral, menderita diare akut, disertai dehidrasiderejat berat berdasar kritesia WHO.

Kriteria eksklusi adalah pasien dengan diare persisten atau diare kronis (>14hari),

pasien dengan riwayat penyakit sistemik (jantung, endokrin, malformasi),kadar ion K < 2 mmol/L, metabolik asidosis berat (pH arteri


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Kelompok NS menerima infus larutan NaCl 0,9% sedangkan kelompok PSmenerima larutan polyelectrolyte yang disiapkan sesuai dengan rumus: Na =97 mmol / L, Cl = 83 mmol / L, glucose = 135,6 mmol / L dan bicarbonate =20 mmol / L (osmolarity = 323 mOsm).

Pemberian perlakuan di kedua kelompok sama yaitu pasien ditimbang dandiukur dengan keadaan telanjang menggunakan skala elektronik (Filizola,

Sa~o Paulo, Brasil) dan skala klinis yang dipantau dengan pemeriksaanfisik. Pengambilan plasma untuk Na, K, Cl, urea, kreatinin, glukosa dan pHarteri dan bikarbonat sebelum dan sesudah fase rehidrasi cepat. Kemudiandilakukan pemberian cairan dengan jumlah 50 ml / kg dalam 1 jam(termasuk 0,3 mmol/kg/jam KCl dan 1 mmol / kg / jam dari HCO3 dikelompok PS).

Data dianalisis dengan menggunakan Epi Info 6.04 (CDC Atlanta, GA) danSPSS 11.0. Distribusi data dikatakan normal dinilai dengan Kolmogorov-

Smirnov Z-test dan hasilnya dinyatakan sebagai sarana dan standar deviasi.Parametrik tes (Student t-test) digunakan untuk membandingkan pasangan(sebelum dan sesudah pengobatan dalam kelompok) atau data independen(antara kelompok perlakuan).


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Dari April 2001 dan April 2002, terdapat 36, 21 di kelompok NS dan 15 pada

kelompok PS. Usia dari kedua kelompok serupa NS (10,2) dan PS (7,6).

distribusi jenis kelamin 67% laki-laki dalam setiap kelompok.

volume rehidrasi adalah kelompok NS 90,5 ml / kg (27,9) dan PS 92,9 ml / kg

(SD 39,7) pada kelompok PS dengan (p=0.84). Durasi rehidrasi = 2,4 (SD 0,97)

dan 2,3 jam (0,91) (p=0.77). Status gizi (stlh rehidrasi) menurut BB//TB

NS=20,56 (SD 1,32) dan PS =20.29 (SD 1,12) (p=0.52).

Na dan K kelompok NS = 5 (24%) hiponatremia (Na


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Gejala system saraf central dikaitkan dengan keadaan hiperglikemiayang spesifik dan dapat juga karena dehidrasi itu sendiri atau kondisilain seperti infeksi sistemik.

NS efektif dalam menggantikan cairan dan natrium pada penderitadehidrasi parah, tetapi cenderung untuk memperburuk

ketidakseimbangan metabolisme, sedangkan PS dapat menanganiasidosis metabolisme tanpa hiperkalemia. PS ini aman, mudahuntuk menangani dan efektif pada dehidrasi berat bayi

Kesimpulan larutan polielectrolit sama efektifnya dengan normalsaline pada perbaikan volume dan lebih baik untuk mengoreksi

asidosis pada keadaan dehidrasi berat balita diare. Kesimpulan larutan polielectrolit sama efektifnya dengan normal

saline pada perbaikan volume dan lebih baik untuk mengoreksiasidosis pada keadaan dehidrasi berat balita diare.


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1. Did the trial

address a

clearly focused

issue?

An issue can be

focused in termsof

The population

studied

The

intervention

givenThe comparator

given

The outcomes

considered

Jawaban: yes

Patients were enrol led at the Emergency Unit of Hos pital

Infant i l Alb ert Sabin,Fortaleza, Ceara, Brazi l who have

severely dehyd rated infants with acute diarrhea before

receiving parenteral f luid th erapy. Between Ap ri l 2001 and

Ap ril 2002 (on page 254).

The polyelectro ly te solu t ion g roup received a polyelectro ly te

solut ion prepared accord ing to th e formula: Na=97 mmo l/L, Cl

=83 mm ol/L, gluco se = 135.6 mmol/L and bic arbon ate = 20

mmol/L (osm olari ty=323 mOsm ). (on page 254).

The normal saline grou p received parenteral infusion of NaCl

0.9% so lut ion . (on page 254).

Primary outcom es were durat ion and volum e of rehydrat ion.Secondary ou tcomes were plasma levels of Na, K, Cl, urea

and c reatinine, and arterial pH and b icarbo nate (HCO3) (o n

page 254).


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2. Was the

assignment of

patient to

treatments

randomized?

Jawaban: yes

Infants wh o met the inclusio n cr i ter ia were randomly

assigned to on e or other treatment b y sort ing a ser ies of

sequent ia l envelopes con tain ing the treatment grou ps to

wh ich patients w ere al loc ated. (On p age 254).

3. Were all of the

patients who

entered the trial

properly accounted

for at its conclusion

Was follow up

complete?Were patients

analysed in the

group to which

they were

randomized?

Jawaban: yes

Between April 2001 and April 2002, 36 children were enrolled

in the study, 21 in the NS group and 15 in the PS group. All

36 patients were successfully rehydrated. All children in both

groups had full peripheral pulses after 1 hr of infusion (On

page 255).

The analyses described here were performed by sorting aseries of sequential envelopes containing the treatment

groups to which patients were allocated on all 36 infants who

were randomly assigned (on page 255).


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4. Were patients,

health workers and

study personnel

blindto treatment?

Were the patients

Were the health

workersWere the study

personnel

Jawaban: No

A comparat ive, random ised, open study o f severely

dehydrated infants who received rapid parenteral

rehydrat ion with NS or a polyelectro ly te solut ion was

undertaken. (on page 254)

5. Were the groups

similar at the start of

the trial?

factors that mighteffect the outcome

such as

age,sex,social class.

Jawaban: yes

Both groups were similar in age (mean 10.2 and 7.6 mths in

the NS and PS groups, respectively (p=0.21), and gender

distribution (67% of males in each group). (on page 255)


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6. Aside from the

experimental

intervention,

were the groups

treated equally?

Jawaban: yes

Normal Sal ine and Po lyelectroly tes Solut ion w ere

admin istered at 50 ml/kg in the 1st hou r (wh ich

included 0.3 mmol/kg/hr of KCl and 1 mmo l/kg/hr

of HCO3-in PS) by co nt inuous in fus ion pump.

When the pat ients w ere reexamin ed and sign s ofdehyd rat ion reassess ed (pulse, capi l lary ref il l t ime

and lethargy or coma), volume flow w as either

kept at 50 m l/kg/hr or redu ced to 25 ml/kg/ hr unt i l

the signs o f severe dehydrat ion resolved (absenc e

of depressed con scious ness, an adequate

per ipheral pu lse or capi l lary ref i l l t ime


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7. How large

was the

treatment

effect?

What

outcomesare

measured?

Jawaban: Mean (SD) rehydration volume was 90.5 ml/kg (27.9) in the

NS gro up and 92.9 ml/kg (39.7) in the PS gro up (p=0.84). (on

page 256).

Duration of rehyd rat ion was 2.4 (0.97) and 2.3 hours (0.91),

resp ectiv ely (p=0.77). (on page 257).

Nutri t io nal status (evaluated after rehyd rat ion) acco rdin g to

the weigh t-for-height Z-sco re was 20.56 in gro up NS (SD

1.32) and 20.29 in g roup PS (SD 1.12) (p=0.52). (on p age

257).

Means (SD) of Na and K . In g roup NS, five (24%) patients

had hy ponatraemia (N


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8. How precise was

the estimate of the

treatment effect?

What are its

confidence limits?

Jawaban: cant tell

Data were analysed u sin g Epi Info 6.04 (CDC Atlanta, GA) and

SPSS 11.0. (on page 255).

No sig nif icant dif ference was o bserved between the Normal Sal in

and Polyelectro lytes Solut ion grou ps in mean t ime to rehydrat ion

or m ean infusio n volum e. Both s olut ions s tudied were ef fect ive ininc reasing p lasma Na in s evere hypo -natraemia. (on p age 258).

But Polyelectro lytes Solut ion bet ter for cor rect ing acidosis and

increase gluco sa. It showed on page 257 Group NS showed a

sig nif ic ant decrease in m ean arterial bicarbo nate (13.3 to 12.2

mm ol/L, p=0.01), suggest ing that metabol ic acidos is can wors en

short ly af ter rapid f lu id infu sion w ith NaCl 0.9% solu t ion, whi le

group PS show ed a sign if icant increase (f rom 11.6 to 13.3 mm ol/L,

p=0.02), ref lect ing the benefits o f early bic arbon ate

administration. And increase glucose showed in grup PS.

Hyperg lyc aemia was present in ten patients (48%) before and in

none after rehydrat ion in grou p NS, whi le in grou p PS it occurr ed

in nine (60%) before and 11 (73%) after treatment, ref lect ing the

ef fect of gluco se administ rat ion in in fants who are dehydrated and

hyperglycaemicat baseline. .


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9. Can the result

be applied to the

local population?

Do you think

that the

patientcovered by

the trial are

similar

enough to

your

population?

Jawaban: Yes.

Severe dehyd rat ion needs to be promptly

corrected with int ra-venous f lu ids in order to re-

establ ish b lood f low to vi tal organs. (on page

257).

It important to replete the con tractedint ravascular space with so dium solut ion, the

extra-vascu lar space w ith potassium , alkali ( to

replace bicarbo nate los ses) and glu cos e to

com pensate previous intake rest r ic t ion and

increased per iphera l glucose cons umpt ion

du r ing d ehyd rat ion. (on page 257).


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10. Were all

clinically

important

outcomes

considered?

If not ,does thisaffect the decision?

Jawaban: yes

There were no d eaths and, after rapid infus ion o f

both so lut ions, no sign s of f lu id over load

(per ipheral oedema, dys pnoea and c rackles or

liver enlargem ent) were observed. (on page 255).

11. Are the benefits

worth the harms

and costs?

This is unlikely tobe addressed by

the trial,but what

do you think?

Jawaban: NoKeuntungan yang dihasilkan dari larutan polielektrolit sama

dibandingkan dengan pemberian normal salin. Walaupun

pada pemerian larutan polielektrolit dapat meningkatkankadar bikarbonat dan kadar glukosa, tetapi larutan tersebut

belum tersedia dan perlu ahli farmasi untuk meraciknya.

Otomatis akan lebih mahal dan lebih rumit dalam

pemberian resusitasi cairan sedangkan dehidrasi pada

diare perlu segera ditolong.


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Najmi Critical Appraisal