Gastroenteritis Aggressive Versus Slow Treatment for Rehydration (GASTRO). A pilot rehydration study for severe dehydration: WHO Plan C versus slower rehydration.
How safe is it to give a slower rehydration regimen to children who have severe dehydration compared to following the WHO Plan C regimen?
What is this study about?
GASTRO was a multi-centre Phase II randomised controlled trial of children aged 2 months to 12 years admitted to hospital in Kenya or Uganda with severe dehydration secondary to acute gastroenteritis. They were randomised to standard rapid dehydration (WHO Plan C – 100mls/kg over 3-6 hours according to age, plus additional boluses for children presenting in shock) or to a slower rehydration regimen (100mls/kg given over 8 hours without additional boluses). The primary outcome was number of adverse events with secondary outcomes focussing on clinical, biochemical and physiological measures related to assessment of severity of dehydration and response to treatment.
Type of study
Who is funding the study?
When is it taking place?
September 2016 to February 2019
Where is it taking place?
Mbale and Soroti in Uganda, Kilifi in Kenya
Who is included?
122 Children aged between 2 months and 12 years with severe dehydration presenting to hospital in Uganda and Kenya. Children with severe malnutrition, known congential or rheumatic heart disease, or diarrhoea lasting more than 14 days were excluded.