Critical Illness, Emergencies, Hypoglycemia Non Diabetics, Pediatric ALL
Conditions
Keywords
pediatric, critical illness, Malawi
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.
Interventions
DRUG10% dextrose
Bolus of 10% dextrose 5mls/kg
Sponsors
Kamuzu University of Health Sciences
Helena Hildenwall
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Months to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In-hospital mortality in children 1 month to 5 years old | Up to 12 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 24 hours mortality in children 1 month to 5 years old | 24 hours after admission | Mortality within the first 24 hrs after admission |
Other
| Measure | Time frame | Description |
|---|---|---|
| In-hospital mortality in children 5-12 years old | Up to 12 months | 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 |
| In hospital mortality in children with initial hypoglycaemia (blood glucose <2.5mmol/l) and low glycemia after first dextrose bolus | Up to 12 months | 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 |
Countries
Malawi
Outcome results
None listed