Gastroenteritis: Rehydration of children with Severe Acute Malnutrition (GASTROSAM)

Principal investigator

New User

Locations

Nigeria, Kenya, Uganda
Topic

Nutrition
Methodology

Randomised controlled trial (RCT)
Reference

OCB024-02
Views

110
Downloaded

1

Purpose of study

Study status

Concept
Protocol & ERB
Implementation
Completion
Archived

Study timeline

Documents

1319-protocol-2023-07-26.pdf 723 KB
1319-msf-erb-approval-2023-07-26.pdf 113 KB

Publications

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Purpose of study

Children hospitalised with severe acute malnutrition (SAM) are frequently complicated (>50%) by diarrhoea ( 3 watery stools/day) which is accompanied by poor outcomes (case fatality 21%). Rehydration guidelines for SAM are exceptionally conservative and controversial, as they rely upon expert opinion, recommending restriction of intravenous (iv) to cases with advanced shock and exclusive use of low sodium intravenous and oral rehydration solutions (ORS) for fear of fluid and/or sodium overload. Our research group have conducted previous research to show that hypotonic solutions for rehydration and shock management resulted in worse outcomes than isotonic Ringers Lactate. Also, an observational study was conducted in Mbale which incorporated detailed investigation of myocardial function and haemodynamic response to intravenous rehydration for SAM children with severe dehydration due to diarrhoea. This study showed a very high mortality of children managed in accordance to WHO SAM rehydration guidelines (80%) with echocardiographic evidence of fluid responsiveness with intravenous rehydration (i.e. that is was safe and resulted in a positive myocardial response to rehydration) but indicated children remained grossly ‘under- filled’, and concluded the need to assess more liberal volumes of fluid rehydration. The proposed GASTROSAM trial is the next step in reappraising current recommendations. We aim to evaluate standard (usually used in non-SAM children) liberal strategies for both iv and oral rehydration in SAM children with diarrhoea. This Phase II trial will generate safety and data on survival to 96 hours, 7 days and 28 days of rehydration strategies incorporating two strata for management of (A) severe dehydration comparing both rates of rehydration and volume of iv replacement and (B) the composition of ORS for children with some dehydration (post iv-rehydration) designed as a partial factorial trial. The two major questions to be addressed are (1) In Stratum A involving SAM children with clinical signs of severe dehydration (approximately 10% loss) whether ‘liberal’ rehydration strategy using 100mls/kg of isotonic Ringers Lactate with either: (i) standard WHO Plan C for rapid rehydration over 3-5 hours (incorporating boluses for shock) versus (ii) slower fixed rate of intravenous rehydration over 8 hours (and no boluses) are safer and result in better outcomes versus (iii) current WHO SAM guidelines recommending oral rehydration with low-sodium ReSoMal and restricting iv to those with advanced shock only (15 ml/kg bolus (plus one repeat). (2) In Stratum B in children with diarrhoea with clinical signs of ‘some dehydration’ and for those in Stratum A (follow on treatment post-intravenous rehydration) whether oral rehydration with (i)WHO standard oral rehydration solution (ORS) for non-SAM results in less hyponatraemia and less adverse outcomes than (ii) current recommendation advocating low sodium (ReSoMal) ORS. There is an urgent need to reappraise the recommendations; since they lack any relevant studies and have largely ignored published data contradicting these opinions and therefore most clinicians are fearful of use of intravenous fluids owing to the very strongly worded warnings about the potential harm. Demonstrating that intravenous rehydration is safe in children with SAM will be an important achievement. Our multidisciplinary group, including experts in child health, infectious diseases, clinical trials and critical illness, are uniquely placed to conduct this research. A number of the co-applicants were involved in the design and conduct of the largest and only controlled of fluid resuscitation, FEAST, in children with shock due to severe febrile illness.