Aims The World Health Organisation (WHO) rehydration guidelines (Plan C) for children with acute gastroenteritis (AGE) and severe dehydration are widely practiced in resource-poor settings, yet have never been evaluated in a clinical trial. GASTRO study will compare the safety and efficacy of two rehydration regimens: standard rapid rehydration (Plan C) versus a slower regimen and inform definitions for outcomes of a larger phase III trial.
Methods GASTRO is a multi-centre, open Phase II randomised controlled trial of 120 children aged 2 months to 12 years admitted with severe dehydration secondary to AGE. Children with severe malnutrition, chronic diarrhoea and known congenital/rheumatic heart disease are excluded. Children are enrolled in 3 centres in East Africa and randomised 1:1 to standard rapid rehydration (WHO plan ‘C’ – 100 mls/kg over 3–6 hours according to age, plus additional boluses for children presenting in shock) or to a slower rehydration regimen (100 mls/kg given over 8 hours and without additional boluses). Primary outcome is frequency of adverse events. Secondary outcomes focus on measures related to assessment of severity of dehydration, and response to treatment.
Results Enrolment is ongoing. By 21 st September 2017 61 children had been enrolled. Baseline characteristics across the two groups are consistent: median age 9 months (IQR 7–14), 67% males, median duration of diarrhoea and vomiting is 3 days, the majority are lethargic, thirsty and irritable on admission (70%) and main features of dehydration are sunken eyes (100%), prolonged skin pinch (64%), reduced/absent tears (100%), dry/sticky mucous membranes (98%). Features of shock (cool peripheries, weak and fast pulse, and prolonged capillary refill) exist in 33% of the patients at admission, and no child had severe hypotension. Median weight loss is 5.7%. We have not completed recruitment and therefore cannot present outcomes at this stage.
Discussion There have been two main challenges when operationalising this trial. Firstly staff training and confidence with ensuring accurate fluid balance documentation. Secondly there has been slow recruitment as a result of national medical strikes and a severe drought across East Africa resulting in higher numbers of children fulfilling severe malnutrition anthropometric criteria and therefore being excluded.
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