Post on 03-Apr-2018
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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
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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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TERIMA KASIH