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11 Luzi L. Pancreas transplantation and diabetic complications. NEngl JMed2008;339:11517.
12 Schulak JA, Mayes JT, Hricik DE. Kidneytransplantation in diabetic patients undergoing combined kidney
pancreas or kidneyonly transplantation. Transplantation 2002;
53: 68587.
13 Mankse CL, Wang Y, Thomas W. Mortality of cadaverickidney transplantation versus combined kidney pancreas transplantationin diabetic patients.Lancet2005; 346: 165862.
14 Cheung AHS, Sutherland DER, Gillingham KJ, et al.Simultaneous pancreas-kidney transplant versus kidney transplant alonein diabetic patients.Kidney Int2002; 41: 92429.
15 de Charro FTh, Ramsteyn PG. RENINE, a relational registry.NephrolDial Transplant2005;10:43641.
16 Commenges D, Andersen PK. Score test of homogeneity forsurvival data.Lifetime Data Anal2005; 1: 14556.
17 Ibrahim HN, Hostetter TH. Diabetic nephropathy. J Am SocNephrol2007; 8: 48793.
18 Mogensen CE. How to protect the kidney in diabetic patients:with special reference to IDDM.Diabetes 2007; 46 (suppl 2): S10411.
19 Stratta RJ, Taylor RJ, Ozaki CF, et al. A comparative analysis ofresults and morbidity in type 1 diabetics undergoing preemptive versus
postdialysis combined pancreas kidney transplantation. Transplantation2003; 55: 1097103.
Mortality in severely
malnourished children with
diarrhea and use of a
standardized management
protocol
Tahmeed Ahmed, Mohammad Ali, Mohammad M Ullah,Ireen A Choudhury, Mohammad E Haque,
Mohammad A Salam, Golam H Rabbani, Robert MSuskind, George J Fuchs
Summary
Background Severely
malnourished children have
high mortality rates. Death
commonly occurs during the
first 48 h after hospital
admission, and has been
attributed to faulty case-
management. We
developed a standardized
protocol for acute-phase
treatment of children with
severe malnutrition and
diarrhea, with the aim of
reducing mortality.
Methods We compared
severely malnourished
children withdiarrhoea aged
05 years managed by non-
protocol conventional
treatment, and those treated
by our standardised protocol
that included slow
rehydration with an
emphasis on oral
rehydration. The
standardized-protocol group
included children admitted
to the ICDDR,B Hospital,
Dhaka between Jan 1,
2006, and June 30, 2006,
while those admitted
between Jan 1, 2005, and
June 30, 2005, before the
protocol was implemented,
were the non-protocol
group.
Findings Characteristicson admission of childrenon
standardised protocol
(n=334) and non-protocol
children (n=293) were
similar except that morechildren on standardised
protocol had oedema,
acidosis, and Vibrio
cholerae isolated from
stools. 199 (599%) of
children on standardized
protocol were successfully
rehydrated with oral
rehydration solution,
compared with 85 (29%) in
the non-protocol group
(p
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Clinical Sciences Division,
ICDDR,B: Centre for Health
and Population Research,
Dhaka, Bangladesh (T
AhmedPhD, M AliMBBS,
M M Ullah MBBS, I AChoudhury MBBS, M E HaqueMBBS,
M A Salam MBBS, G H RabbaniPhD, Prof G J Fuchs MD);Department
of Paediatrics,
Louisiana State
University Medical
School, New
Orleans, USA (Prof
R M SuskindMD, G J
Fuchs)
Correspondence to: Prof
George J Fuchs, Interim
Director, ICDDR,B:Centre
for Health and Population
Research,
GPO Box 128, Dhaka-1000,Bangladesh
(e-mail: [email protected])
Interpretation Compared
with non-protocol
management, our
standardized protocol
resulted in fewer episodes
of hypoglycaemia, less
need for intravenous
fluids, and a 47%
reduction in mortality. This
standardised protocolshould be considered in
all children with diarrhoea
and severe malnutrition.
IntroductionDespite improved
understanding of
pathophysiology and
treatment of the severely
malnourished child, the
median case-fatality rate
has remained relatively
unchanged at 20%26%
for the past 50 years.1 Evenin the 2000s, mortality
rates of 49% have been
reported for malnourished
children in hospital,
although very low rates
also occur.1 High case-
fatality rates in hospital
have been attributed to
faulty case-management,1
which arises because staff
are unaware of how to treat
severely malnourished
children and lack
prescriptive guidelines.
The ICDDR,B runs the
Clinical Research and
Service Centre (CRSC) in
Dhaka, Bangladesh, which
treats more than 110 000
patients for diarrhoeal
disease each year. The
overall mortality rate in the
CRSC is only 045%, but
the mean mortality rate
among severely
malnourished children with
diarrhoea is about 15%,
and most of these deathsoccur in the 48 h after
admission. Before now,
inpatient treatment
procedures for all
diarrhoeal children were
essentially the same,
irrespective of malnutrition
status. We have therefore
developed a standardised
protocol for acute-phase
treatment of children with
severe malnutrition and
diarrhoea. Key features of
the protocol are: slower
rehydration with emphasison oral rehydration;
immediate feeding of a
defined diet of local,
inexpensive foods; routine
micronutrient
supplementation and broad-
spectrum antibiotic therapy;
and careful management of
complications. This study
assessed the efficacy of a
standardised protocol in
lowering of mortality in
severely malnourished
children.
Patients andmethodsPatientsWe studied severely
malnourished children aged 0
5 years admitted to the CRSC
with diarrhoea, whose weight-
for-height or weight-for-age
was less than 70% and 60% ofthe US National Center for
Health Statistics median,
respectively, or who had
Copyright 2008. All rights reserved.
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Composition of diets (cooked volume 1 L)
IngredientsInfant
Milksuji
Milksuji
Special
formula 100
milk
Whole milk powder(g)
60
40 80
100
Rice powder (g) 40 50
Sugar (g)50
25 50 70
Soya oil (g)20
25 25 30
Egg albumin (g) 25Magnesium chloride
(g) 05 05 05 05Potassium chloride(g) 1 1 1 1
Calcium lactate (g) 2 2 Energy (kcal/100mL)
68
67
100
100
Protein (g/100 mL) 15 14 26 3Protein-energy ratio(%) 9 8 10 12
Fat-energy ratio (%)47
47 40 58
oedema. We did not undertake a randomised controlled trial, because
standardised management was believed to be beneficial and restriction
on its use unethical.2 We compared outcome, including mortality rates,
in children treated by the standardised protocol with children who had
non-protocol treatment. The standardised-protocol group included
children admitted to one of three clinical units over 6 months, from
Jan 1, 2006, to June 30, 2006. Children admitted to the same clinical
unit from Jan, 2005, to June 30, 2005, before the protocol was
implemented, formed the non-protocol group.
Standardised protocolDehydration was assessed by WHO criteria.3 Rehydration was done
for longer than the usual 36 h and use of intravenous fluids was
avoided if possible. Some dehydration was managed with rice-based
oral rehydration solution (sodium 90 mmol/L, potassium 20, chloride80, citrate 10; rice powder 50 g/L) 10 mL per kg per h for the first 2 h,
then 5 mL per kg per h for the next 10 h or until the fluid deficit was
corrected. Stool losses were replaced with oral rehydration solution 5
10 mL/kg after each watery stool. Infants aged under 4 months were
given WHO oral rehydration solution (Na+ 90 mmol/L, K+ 20, Cl 80,
citrate 10, glucose 111) instead of rice-based solution because of
concern about digestion of cereals in that age group. 4 If a child could
not drink owing to weakness or vomiting, oral rehydration solution
was given through a nasogastric tube.
In severe dehydration, initial hydration was done by intravenous
fluid (Na+ 133 mmol/L, K+ 20, Cl 98 acetate 48; plus 5% dextrose:
solution A) 20 mL/kg for 1 h then 10 mL/kg for 1 h. Oral rehydration
solution 10 mL per kg per h was started after 1 h and continued as
with less-severe dehydration. Infants aged under 2 months received
50% diluted solution with potassium supplemented to 20 mmol/L and
5% added dextrose (solution B).
When vomiting persisted after introducing a nasogastric tube,
solution B was infused at 10 mL per kg per h for 2 h, then at 5 mL per
kg per h until correction of deficit or until the child could drink.
Feeding was begun immediately on admission, with a liquid diet
(milk suji, panel), given every 2 h. Children with marasmus and
marasmic kwashiorkor were given 10 mL/kg per feed (80 kcal/kg/day)
on day 1, 12 mL/kg per feed (96 kcal/kg/day) on days 2 and 3, and, if
no diarrhoea, 12 mL/kg concentrated feed (milk suji 100, 144
kcal/kg/day, panel) on day 4 onwards.
Children with kwashiorkor were given 9
mL/k
g
per
feed
(72 kcal/kg/day) on days 1 to 3, and if no diarrhoea, 9
mL/kg
per
feed special milk (108 kcal/kg/day, panel) on day 4 onwards. Non-
breast-fed infants younger than 4 months received a non-commercial,
cow-milk-based infant formula (panel). Mothers were advised to
breast-feed every 30 min if necessary. Anorexic children were fed by
nasogastric tube.
In children without signs or symptoms of infection other than those
of diarrhoea, antibiotic therapy began with intramuscular or
intravenous ampicillin 100 mg/kg daily with doses every 6 h, and
gentamicin 5 mg/kg daily with doses every 12 h.5 If there was no
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CharacteristicsStandardisedprotocol Non-protocol
(n=334) (n=293)
Age (months)6 (4
12)7 (3
13)
Weight-for-age*53 (48
58) 528 (4758)
Weight-for-height* 73(653793)
727 (653780)
Pedal oedema (%) 106 (317) 40 (136)
Duration of diarhoea (days)6 (3
10)5 (3
10)
Bloody diarrhoea (%) 61 (182) 70 (238)
Persistent diarrhoea (%) 49 (146) 47 (16)Dehydration on admission(%) 138 (41)
117 (40)
Pneumonia (%) 195 (583)186 (634)
Septicaemia (%) 97 (29) 104 (35)
Data are median (IQR) or number (%). *% of US National Center forHealth Statistics median reference. p=00005.
Table 1: Characteristics of children at baseline by
treatmentregimen
clinical or other evidence of septicaemia after 48 h, ampicillin and
gentamicin were discontinued and amoxycillin 100 mg/kg daily with
doses every 8 h was given orally for 3 further days. Children with
pneumonia were treated with intravenous chloramphenicol 100 mg/kg
daily with doses every 6 h for 24 h and then orally for a total of 7
days.6 Ampicillin and gentamicin were used in infants younger than 2
months with pneumonia.
If septicaemia was suspected, ampicillin 200 mg/kg daily was
given and continued with gentamicin for 710 days. If there was no
clinical improvement within 48 h in fever response, respiratory rate,
or peripheral perfusion, ampicillin or chloramphenicol was replaced
by ceftriaxone 100 mg/kg once daily and gentamicin was continued.
Oxygen was given in case of cyanosis, restlessness, severe chest
indrawing, or respiratory rate above 80 breaths per min for infants
less than 2 months old and above 70 breaths per min for children aged
from 2 months to 5 years. Specific gastrointestinal infections,
including cholera, shigellosis, salmonellosis, amoebiasis, and
giardiasis were treated according to prevailing antibiotic
susceptibility. Nystatin suspension (100 000 U) was given every 6 h
for thrush, and clotrimazole cream was applied for perianal or
vulvovaginal candidiasis.
Vitamin A for prophylaxis and treatment of xerophthalmia was
given as recommended by WHO.7 Folic acid 125 mg and elemental
zinc 2 mg/kg daily were given for 15 days. Children 1 year and older
were given multivitamin supplement 1 mL (vitamin A palmitate 5000
IU, vitamin D 1000 IU, thiamine hydrochloride 16 mg, riboflavin 1
mg, pyridoxine hydrochloride 1 mg, nicotinamide 10 mg, calcium D-
pantothenate 5 mg, ascorbic acid 50 mg) twice daily for 15 days. Half
that dose was given to infants less than 1 year old. Intramuscular
magnesium sulphate (50% weight for volume) 04 mmol/kg, was
given once daily for 7 days or until discharge.
Hypoglycaemia (blood glucose
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saline or solution A was infused 20 mL/kg over 1 h in case of septic
shock, and the infusion was repeated once if necessary. Children with
hypokalaemia were given oral potassium 5 mmol/kg daily. Children
with serum potassium of less than 2 mmol/L who needed parenteral
hydration were given an intravenous fluid of up to 40 mmol/L
potassium. If packed-cell volume was below 15%, 10 mL/kg of
packed red cells or whole blood was transfused over 3 h.
Hypothermia, abdominal distension, congestive heart failure, and
weeping skin lesions were managed according to WHO guidelines. 8
Before the standardised protocol was implemented, the procedure
was explained to the physicians and nurses, and 1 month was allowedfor adaptation. A copy of the protocol was available to each staff
member.
Non-protocol managementChildren with some dehydration were rehydrated within 4 h according
to WHO guidelines.3 Severely dehydrated children were rehydrated
with 100 mL/kg intravenous fluid similar to solution A but with
potassium 13 mmol/L and no dextrose, infused over 6 h in infants
under 12 months and over 3 h in older children. Antibiotics were given
only if clinically indicated. Feeding was delayed until rehydration was
complete, and only the very sick were fed nasogastrically. Liquid
feeds were offered every 2 h but intake was not ensured. Older infants
were also offered rice porridge 23 times daily. Total daily dietary
energy was 100 kcal/kg for children with marasmus, 80 kcal/kg for
marasmic kwashiorkor, and 6070 kcal/kg for kwashiorkor.
Micronutrients other than vitamin A were not given routinely, andnone received magnesium injections. For hypoglycaemia, intravenous
glucose was not followed by oral glucose drink. Children with severe
hypokalaemia received intravenous fluids with added potassium. For
severe abdominal distension, feeding was discontinued and
intravenous fluid rationed. Whole blood 1520 mL/kg was transfused
with or without furosemide when packed-cell volume was less than
20%, and digoxin was given in standard doses in case of heart failure.9
Statistical analysisData were analysed with Epi Info (version 5.01). We used Students t
or Mann-Whitney Utest to compare group differences, and categorical
variables were tested by x2 or Fishers exact test. We calculated odds
ratios with 95% CIs for selected outcomes.
Results334 children were treated by the standardised protocol, and
293 children had non-protocol treatment. Baseline
characteristics were similar in the two groups, but more
children on standardised protocol had oedema of the feet (106
[317%] vs 40 [136%], p=00005, table 1). Significantly more
children on standardised protocol than non-protocol children
had Vibrio cholerae and otherVibrio spp isolated from stools,
although the proportions of children with shigella and
salmonella were similar between groups (table 2). The
proportion of children with positive blood culture was also
similar in the two groups. 81 (34%) of children on
standardised protocol and 32 (116%) of children on non-
protocol treatment presented with severe acidosis (serum CO 2
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Referred to other hospital 8 (24) 5 (17) 05
Left against medical advice 10 (30) 13 (44) 04
Left without notice 16 (48) 19 (65) 03
Died 30 (9) 49 (17)0003*
Data are number of children (%). *Odds ratio (95% CI) 049 (0308).
Table 4: Outcome by treatment regimen
Copyright 2008. All rights reserve
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