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SugarFACT - Sugar Requirements For African Children Trial

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ClinicalTrials.gov Identifier: NCT02989675
Recruitment Status : Terminated
First Posted : December 12, 2016
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
University of Malawi College of Medicine
Information provided by (Responsible Party):
Helena Hildenwall, Karolinska Institutet

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.


Condition or disease Intervention/treatment Phase
Hypoglycemia Non Diabetics Emergencies Pediatric ALL Critical Illness Drug: 10% dextrose Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 410 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: SugarFACT - Sugar Requirements For African Children Trial
Study Start Date : December 2016
Actual Primary Completion Date : January 22, 2019
Actual Study Completion Date : January 22, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arm Intervention/treatment
Experimental: Dextrose
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
Bolus of 10% dextrose 5mls/kg

No Intervention: Control
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.



Primary Outcome Measures :
  1. In-hospital mortality in children 1 month to 5 years old [ Time Frame: 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 Outcome Measures :
  1. 24 hours mortality in children 1 month to 5 years old [ Time Frame: 24 hours after admission ]
    Mortality within the first 24 hrs after admission


Other Outcome Measures:
  1. In-hospital mortality in children 5-12 years old [ Time Frame: 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

  2. In hospital mortality in children with initial hypoglycaemia (blood glucose <2.5mmol/l) and low glycemia after first dextrose bolus [ Time Frame: 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



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Ages Eligible for Study:   1 Month to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02989675


Locations
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Malawi
Queen Elisabeth Central Hospital
Blantyre, Malawi
Zomba Central Hospital
Zomba, Malawi
Sponsors and Collaborators
Helena Hildenwall
University of Malawi College of Medicine
Investigators
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Principal Investigator: 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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Helena Hildenwall, MD, PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02989675    
Other Study ID Numbers: P.01/16/1852
First Posted: December 12, 2016    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Keywords provided by Helena Hildenwall, Karolinska Institutet:
pediatric
critical illness
Malawi
Additional relevant MeSH terms:
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Hypoglycemia
Emergencies
Critical Illness
Disease Attributes
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases