SugarFACT - Sugar Requirements For African Children Trial
Status:
Terminated
Trial end date:
2019-01-22
Target enrollment:
Participant gender:
Summary
The purpose of this study is to evaluate the impact of dextrose administration in severely
sick children admitted to hospital with low-glycaemia.
The problem: Mortality in children remains high in sub-Saharan African hospitals. While
antimalarial drugs, antibiotics and other definitive treatments are well understood, the role
of emergency care with supportive therapies such as maintaining normal glucose and
electrolyte balances, has been given limited attention. Hypoglycaemia is common in children
admitted to hospital in low-income settings. The current definition of hypoglycaemia is a
blood glucose level of less than 2.5mmol/l. Outcomes for these children are poor, with a
mortality rate of up to 42%. An increased mortality has also been reported among acutely ill
children with low-glycaemia, defined as a blood glucose level of 2.5-5.0mmol/l. The reason
for increased mortality rates is not fully understood.
Study objective: To determine the impact on mortality of a raised treatment cut-off level for
paediatric hypoglycaemia, from 2.5mmol/l to 5.0mmol/l.
Methodology: Severely ill children admitted to two central Malawian hospitals; Queen
Elisabeth Central Hospital, Blantyre and Zomba Central Hospital, with low-glycaemia
(2.5-5.0mmol/l) will be randomised into intervention or control groups. The intervention
group will be treated with an intravenous bolus of 10% dextrose 5ml/kg followed by a dextrose
infusion in addition to standard care while the control group will receive standard care
only. Children will be followed until discharge from hospital or death. Primary end-point is
in-hospital mortality.