SugarFACT - Sugar Requirements For African Children Trial

Critical Illness Clinical Trial

Official title:

SugarFACT - Sugar Requirements For African Children Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02989675
• Other study ID #: P.01/16/1852
• Status: Terminated
• Phase: N/A
• Start date: December 2016
• Est. completion date: January 22, 2019

Study information

• Verified date: February 2019
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 410
• Est. completion date: January 22, 2019
• Est. primary completion date: January 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 12 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• 10% dextrose
Bolus of 10% dextrose 5mls/kg

Locations

Country	Name	City	State
Malawi	Queen Elisabeth Central Hospital	Blantyre
Malawi	Zomba Central Hospital	Zomba

Sponsors (2)

Lead Sponsor	Collaborator
Helena Hildenwall	University of Malawi College of Medicine

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	In-hospital mortality in children 5-12 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
Other	In hospital mortality in children with initial hypoglycaemia (blood glucose <2.5mmol/l) and low glycemia after first dextrose bolus	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
Primary	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	24 hours mortality in children 1 month to 5 years old	Mortality within the first 24 hrs after admission	24 hours after admission