SugarFACT - Sugar Requirements For African Children Trial

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.

Conditions

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

Interventions

DRUG

10% dextrose

Bolus of 10% dextrose 5mls/kg

Sponsors & Collaborators

• Kamuzu University of Health Sciences

  collaborator OTHER

• Helena Hildenwall

  lead OTHER

Principal Investigators

• Helena Hildenwall, MD, PhD · Karolinska Institutet

• Tim Baker, MD, PhD · Karolinska Institutet

• Queen Dube, MD, PhD · College of Medicine, Malawi

• Josephine Langton, MD · College of Medicine, Malawi

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

1 Month

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-12-31

Primary Completion

2019-01-22

Completion

2019-01-22

Countries

• Malawi

Study Locations