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Gastroenteritis Rehydration Of children with Severe Acute Malnutrition (GASTROSAM): A Phase II Randomised Controlled
Peter Olupot-Olupot1,2, Florence Aloroker3, Ayub Mpoya4
1Department of Paediatrics, Mbale Clinical Research Institute, Pallisa Road, Mbale, PO Box 291, Uganda.
Insights
Liberal rehydration strategies may improve outcomes for children with severe acute malnutrition (SAM) and diarrhea. The GASTROSAM trial is testing if these approaches reduce mortality and adverse events in hospitalized children.
Area of Science:
- Pediatric Gastroenterology
- Infectious Diseases
- Global Health
Background:
- Severe acute malnutrition (SAM) in children is frequently complicated by diarrhea, leading to poor outcomes.
- Current rehydration guidelines for SAM are conservative, using low-sodium solutions and limiting intravenous fluids, contributing to high mortality rates.
- Existing expert-opinion-based guidelines for fluid and electrolyte management in SAM children with diarrhea are controversial.
Purpose of the Study:
- To reappraise current rehydration recommendations for children with SAM and diarrhea, using mortality as the primary outcome.
- To investigate if liberal rehydration strategies, both intravenous and oral, can reduce adverse outcomes in this vulnerable population.
- To compare the safety and efficacy of standard WHO oral rehydration salts (ORS) versus low-sodium ReSoMal in children with moderate and severe dehydration.
Main Methods:
- An open Phase II trial with a partial factorial design conducted in Uganda, Kenya, Nigeria, and Niger.
- Enrollment of children aged 6 months to 12 years with SAM, gastroenteritis, and moderate to severe dehydration.
- Stratified randomization: Stratum A (severe dehydration) compared WHO Plan C, slow rehydration, and WHO SAM regime; Stratum B (moderate dehydration and post-IV) compared standard WHO ORS and ReSoMal.
Main Results:
- Primary outcome for intravenous rehydration: mortality to 96 hours.
- Primary outcome for oral rehydration: change in sodium levels at 24 hours post-randomization.
- Secondary outcomes included safety assessments like pulmonary edema and heart failure, electrolyte balance, and changes in sodium levels.
Conclusions:
- The GASTROSAM trial aims to provide evidence-based recommendations for rehydration in SAM.
- Positive findings could lead to revisions in current treatment guidelines for pediatric malnutrition and diarrhea.
- Results may inform future large-scale Phase III trials to further validate liberal rehydration strategies.
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 will reappraise current recommendations with mortality as the primary outcome. 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 children in Uganda, Kenya, Nigeria and Niger 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 (IV) 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 mortality to 96 hours and for oral rehydration a change in sodium levels at 24 hours post-randomisation. Secondary outcomes include measures assessing safety (evidence of pulmonary oedema or heart failure); change in sodium from post-iv levels for those in Stratum A; perturbations of electrolyte abnormalities (severe hyponatraemia <125 mmols/L or hypokalaemia.
Discussion:
If the trial shows that rehydration strategies for non-malnourished children are safe and improve mortality in SAM this could prompt revisions to the current treatment recommendations or may prompt future Phase III trials.
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