NCT02989675

SugarFACT - Sugar Requirements For African Children Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 410 (actual)
• Sponsor: Helena Hildenwall · Academic / Other
• Sex: All
• Age: 1 Month – 12 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Enrolment started at Queen Elisabeth Central Hospital on Dec 5th 2016. Due to a slow enrolment rate a second site at Zomba Central Hospital has been opened to start enrolment on October 17th, 2017 in order for the project to be completed in December 2019.

Conditions

• Hypoglycemia Non Diabetics
• Emergencies
• Pediatric ALL
• Critical Illness

Interventions

Type	Name	Description
DRUG	10% dextrose	Bolus of 10% dextrose 5mls/kg

Timeline

• Start date: 2016-12-01
• Primary completion: 2019-01-22
• Completion: 2019-01-22
• First posted: 2016-12-12
• Last updated: 2019-02-15

Locations

2 sites across 1 country: Malawi