Gastroenteritis Rehydration Of children with Severe Acute Malnutrition (GASTROSAM): A Phase II Randomised Controlled trial: Trial Protocol

Wellcome Open Research

article

Peter Olupot-Olupot¹  Florence Aloroker³  Ayub Mpoya⁴  Hellen Mnjalla⁴  George Passi¹  Margaret Nakuya²  Kirsty Houston⁵  Nchafatso Obonyo⁴  Mainga Hamaluba⁴  Jennifer A Evans⁶  Roisin Connon⁷  Elizabeth C George⁷  Diana M Gibb⁷  Kathryn Maitland⁴ 

[1] Department of Paediatrics, Mbale Clinical Research Institute;Mbale Regional Referral Hospital;Department of Paediatrics, Soroti Regional Referral Hospital;Clinical Trials Facility, KEMRI-Wellcome Trust Research Programme;Department of Medicine, Imperial College London;Department of Paediatrics, University Hospital of Wales;MRC Clinical Trials Unit at University College London, University College London

关键词: Severe Malnutrition;    Gastroenteritis;    African Children;    Intravenous fluids;    WHO guidelines;    Dehydration;    Rehydration;   

DOI  :  10.12688/wellcomeopenres.16885.1

学科分类：内科医学

来源: Wellcome

【 摘 要 】

Background: 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 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.

【 授权许可】

CC BY