SugarFACT - Sugar Requirements For African Children Trial

NCT02989675 | Terminated DMC

• 1 other identifier: P.01/16/1852
• Study Type: interventional
• Target: 410
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

pediatric; critical illness; Malawi

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 24 hours mortality in children 1 month to 5 years old

  24 hours after admission

Other Outcomes (2)

• In-hospital mortality in children 5-12 years old

  Up to 12 months

• In hospital mortality in children with initial hypoglycaemia (blood glucose <2.5mmol/l) and low glycemia after first dextrose bolus

  Up to 12 months

Study Arms (2)

Dextrose

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

10% dextrose DRUG

Bolus of 10% dextrose 5mls/kg

Dextrose

Eligibility Criteria

• Age: 1 Month - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Children with a known diagnosis of diabetes
• Refusal to participate by the child or guardians

Sponsors & Collaborators

• Helena Hildenwall: lead
• Kamuzu University of Health Sciences: collaborator

Study Sites (2)

Queen Elisabeth Central Hospital

Blantyre, Malawi

Location

Zomba Central Hospital

Zomba, Malawi

Location

Related Publications (2)

• Baker T, Ngwalangwa F, Masanjala H, Dube Q, Langton J, Marrone G, Hildenwall H. Effect on mortality of increasing the cutoff blood glucose concentration for initiating hypoglycaemia treatment in severely sick children aged 1 month to 5 years in Malawi (SugarFACT): a pragmatic, randomised controlled trial. Lancet Glob Health. 2020 Dec;8(12):e1546-e1554. doi: 10.1016/S2214-109X(20)30388-0. Epub 2020 Oct 8.

  PMID: 33038950 DERIVED

• Baker T, Dube Q, Langton J, Hildenwall H. 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. Trials. 2018 Jan 11;19(1):33. doi: 10.1186/s13063-017-2411-8.

  PMID: 29325595 DERIVED

MeSH Terms

Conditions

Emergencies; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Critical Illness

Interventions

Glucose

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Helena Hildenwall, MD, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• Tim Baker, MD, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• Queen Dube, MD, PhD

  College of Medicine, Malawi

  PRINCIPAL INVESTIGATOR

• Josephine Langton, MD

  College of Medicine, Malawi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 5, 2016
• First Posted: December 12, 2016
• Study Start: December 1, 2016
• Primary Completion: January 22, 2019
• Study Completion: January 22, 2019
• Last Updated: February 15, 2019

Record last verified: 2019-02

Locations

MA (2)