Clinical trial NCT02989675: SugarFACT - Sugar Requirements For African Children Trial
Official title: SugarFACT - Sugar Requirements For African Children Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hypoglycemia Non Diabetics
Emergencies
Pediatric ALL
Critical Illness
Keywords: pediatric
critical illness
Malawi
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Kamuzu University of Health Sciences
First posted: 2016-12-12
Enrollment: 410
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: In-hospital mortality in children 1 month to 5 years old
timeFrame: Up to 12 months
Secondary outcomes:
measure: 24 hours mortality in children 1 month to 5 years old
timeFrame: 24 hours after admission
Other outcomes:
measure: In-hospital mortality in children 5-12 years old
timeFrame: Up to 12 months
measure: In hospital mortality in children with initial hypoglycaemia (blood glucose <2.5mmol/l) and low glycemia after first dextrose bolus
timeFrame: Up to 12 months
Locations:
city: Blantyre
country: Malawi
facility: Queen Elisabeth Central Hospital
city: Zomba
country: Malawi
facility: Zomba Central Hospital
Study officials:
affiliation: Karolinska Institutet
name: Helena Hildenwall, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska Institutet
name: Tim Baker, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: College of Medicine, Malawi
name: Queen Dube, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: College of Medicine, Malawi
name: Josephine Langton, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.