Gastroenteritis rehydration of children with severe acute malnutrition (GASTROSAM): a phase II randomised controlled trial: trial protocol
File(s)GASTRO_SAM protocolPaper.pdf (1.8 MB)
Published version
Author(s)
Type
Journal Article
Abstract
Background: Children hospitalised with severe acute malnutrition (SAM) are frequently complicated (>50%) by diarrhoea ( ≥3 watery stools/day) which is accompanied by poor outcomes. Rehydration guidelines for SAM are exceptionally conservative and controversial, based upon expert opinion. The guidelines only permit use of intravenous fluids for cases with advanced shock and exclusive use of low sodium intravenous and oral rehydration solutions (ORS) for fear of fluid and/or sodium overload. Children managed in accordance to these guidelines have a very high mortality. The proposed GASTROSAM trial is the first step in reappraising current recommendations. We hypothesize that liberal rehydration strategies for both intravenous and oral rehydration in SAM children with diarrhoea may reduce adverse outcomes. Methods An open Phase II trial, with a partial factorial design, enrolling Ugandan and Kenyan children aged 6 months to 12 years with SAM hospitalised with gastroenteritis (>3 loose stools/day) and signs of moderate and severe dehydration. In Stratum A (severe dehydration) children will be randomised (1:1:2) to WHO plan C (100mls/kg Ringers Lactate (RL) with intravenous rehydration given over 3-6 hours according to age including boluses for shock), slow rehydration (100 mls/kg RL over 8 hours (no boluses)) or WHO SAM rehydration regime (ORS only (boluses for shock (standard of care)). Stratum B incorporates all children with moderate dehydration and severe dehydration post-intravenous rehydration and compares (1:1 ratio) standard WHO ORS given for non-SAM (experimental) versus WHO SAM-recommended low-sodium ReSoMal. The primary outcome for intravenous rehydration is urine output (mls/kg/hour at 8 hours post-randomisation), and for oral rehydration a change in sodium levels at 24 hours post-randomisation. This trial will also generate feasibility, safety and preliminary data on survival to 28 days. Discussion. If current rehydration strategies for non-malnourished children are safe in SAM this could prompt future evaluation in Phase III trials.
Date Issued
2021-06-23
Date Acceptance
2021-06-21
Citation
Wellcome Open Research, 2021, 6 (160), pp.1-16
ISSN
2398-502X
Publisher
F1000Research
Start Page
1
End Page
16
Journal / Book Title
Wellcome Open Research
Volume
6
Issue
160
Copyright Statement
© 2021 Olupot-Olupot P et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
License URL
Identifier
https://wellcomeopenresearch.org/articles/6-160/v1
Subjects
African Children
Dehydration
Gastroenteritis
Intravenous fluids
Rehydration
Severe Malnutrition
WHO guidelines
Publication Status
Published
Date Publish Online
2021-06-23