SugarFACT - Sugar Requirements For African Children Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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SugarFACT - Sugar Requirements For African Children Trial

Conditions
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Hypoglycemia Non Diabetics, Emergencies, Pediatric ALL, Critical Illness

Intervention / Treatment
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* Drug: 10% dextrose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between one month to 5 years (5 to 12 years for outcome measure no 3) Parent/carer willing and able to give consent Presence of one or several emergency signs (as defined in WHO pocket book of hospital care for children) Obstructed or absent breathing Central cyanosis Severe respiratory distress Shock/impaired perfusion Coma/reduced consciousness Convulsions Severe dehydration Clinical concern that the child is in an emergency state Blood glucose 2.5-5.0mmol/l at arrival to the emergency department (3.0-5.0mmol/l for severely malnourished children). For outcome measure no 4 children with <2.5 mmol/l on arrival who then have 2.5-5.0 mmol/l on the repeat test 30 minutes later are also included Exclusion Criteria: Children with a known diagnosis of diabetes Refusal to participate by the child or guardians

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dextrose<br>Children in the intervention group will immediately receive intravenous 5ml/kg 10% dextrose, Dextrose administration will continue as a maintenance infusion of intravenous 10% dextrose for 24 hours at standard maintenance rates. Capillary blood glucose monitoring will be repeated at 30 minute intervals with repeated equivalent bolus doses given until levels reach ≥5.0mmol/l. All children will be kept in the emergency department for a minimum of 60 minutes and have their vital signs checked at discharge from the emergency room to the ward. | Drug: 10% dextrose<br>* Bolus of 10% dextrose 5mls/kg<br>|
| No Intervention: Control<br>Usual care - the care that is currently provided in the hospital - will be provided. All children in the control group will be kept in the emergency department for a minimum of 60 minutes and have their vital signs checked at discharge from the emergency room to the ward. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-hospital mortality in children 1 month to 5 years old | From date of randomization until the date of discharge from hospital or date of in-hospital death, whichever came first, assessed up to 12 months | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 hours mortality in children 1 month to 5 years old | Mortality within the first 24 hrs after admission | 24 hours after admission | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric, critical illness, Malawi