Mortality impact of an increased blood glucose cut-off level for hypoglycaemia treatment in severely sick children in Malawi (SugarFACT trial): study protocol for a randomised controlled trial

Abstract

Background: 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 < 2.5 mmol/L in a well-nourished child. 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 2.5-5.0 mmol/L. The reason for increased mortality rates is not fully understood. This proposal is for a randomised controlled trial to determine the impact on mortality of a raised treatment cut-off level for paediatric hypoglycaemia.

Methods: A total of 1266 severely ill children (age range = 1 month - 5 years) admitted to Queen Elizabeth Central Hospital in Blantyre, Malawi with blood glucose in the range of 2.5-5.0 mmol/L will be randomised into intervention or control groups. The intervention group will be treated with an intravenous bolus of 10% dextrose 5 mL/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.

Discussion: The first patient was enrolled in December 2016 and the expected trial deadline is January 2019. This study is the first to evaluate the benefits of increased dextrose administration in children presenting to hospital with low-glycaemia. The findings will inform national and international policies and guidelines for the management of children with blood sugar abnormalities.

Trial registration: ClinicalTrials.gov, NCT02989675 . Registered on 5 December 2016.

Keywords: Critical care; Emergency medicine; Hypoglycaemia; Paediatrics.

Conflict of interest statement

Ethics approval and consent to participate

Ethical permission has been approved by the Research and Ethics Committee at the University of Malawi’s College of Medicine (COMREC P.01/16/1852) and by the Central Ethical Research Board in Sweden (EPN 2017/33-31/4). Eligible patients will be identified by study staff in the paediatric A&E. If fulfilling inclusion criteria, a study nurse or clinician will approach the guardian and provide information about the study in Chichewa, the local language in Blantyre, or in English. Information will be given in or close to the Emergency room at the paediatric A&E, depending on the severity of the child’s presentation. After receiving detailed study information, guardians will be asked to provide written consent for their child to participate in the study (Additional file 3). However, since some children will be in need of immediate emergency care, complete study information before provision of dextrose may not always be possible and, in this case, full study information will be deferred to after stabilisation of the child. If consent is denied after stabilisation or if the child dies, no data will be collected from the patient or guardian. In addition to consent, assent from children aged > 7 years is sought. Enrolment will not be possible in patients who have already initiated treatment.

If consent is withdrawn after enrolment in the study, no additional data will be collected and patients will consequently not be part of the primary analysis. Already collected data may be used to identify whether any certain patient group is more likely to withdraw from study.

All research personnel are certified in Good Clinical Practice. No personal identification data will be entered into the CRFs or stored in the database to maintain confidentiality. All study participants will be covered by trial insurance from the day of enrolment in the study and until five years after study closure, following Malawi National Council for Science and Technology guidelines [21]. The final trial dataset will be kept by the College of Medicine for a minimum of five years after study closure and access will be limited to the study investigators.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

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Figures

Fig. 1

Study flowchart

Fig. 2

SugarFACT schedule of enrolment, interventions and assessments