<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02989675</url>
  </required_header>
  <id_info>
    <org_study_id>P.01/16/1852</org_study_id>
    <nct_id>NCT02989675</nct_id>
  </id_info>
  <brief_title>SugarFACT - Sugar Requirements For African Children Trial</brief_title>
  <official_title>SugarFACT - Sugar Requirements For African Children Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Helena Hildenwall</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kamuzu University of Health Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Karolinska Institutet</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the impact of dextrose administration in severely&#xD;
      sick children admitted to hospital with low-glycaemia.&#xD;
&#xD;
      The problem: Mortality in children remains high in sub-Saharan African hospitals. While&#xD;
      antimalarial drugs, antibiotics and other definitive treatments are well understood, the role&#xD;
      of emergency care with supportive therapies such as maintaining normal glucose and&#xD;
      electrolyte balances, has been given limited attention. Hypoglycaemia is common in children&#xD;
      admitted to hospital in low-income settings. The current definition of hypoglycaemia is a&#xD;
      blood glucose level of less than 2.5mmol/l. Outcomes for these children are poor, with a&#xD;
      mortality rate of up to 42%. An increased mortality has also been reported among acutely ill&#xD;
      children with low-glycaemia, defined as a blood glucose level of 2.5-5.0mmol/l. The reason&#xD;
      for increased mortality rates is not fully understood.&#xD;
&#xD;
      Study objective: To determine the impact on mortality of a raised treatment cut-off level for&#xD;
      paediatric hypoglycaemia, from 2.5mmol/l to 5.0mmol/l.&#xD;
&#xD;
      Methodology: Severely ill children admitted to two central Malawian hospitals; Queen&#xD;
      Elisabeth Central Hospital, Blantyre and Zomba Central Hospital, with low-glycaemia&#xD;
      (2.5-5.0mmol/l) will be randomised into intervention or control groups. The intervention&#xD;
      group will be treated with an intravenous bolus of 10% dextrose 5ml/kg followed by a dextrose&#xD;
      infusion in addition to standard care while the control group will receive standard care&#xD;
      only. Children will be followed until discharge from hospital or death. Primary end-point is&#xD;
      in-hospital mortality.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Enrolment started at Queen Elisabeth Central Hospital on Dec 5th 2016. Due to a slow&#xD;
      enrolment rate a second site at Zomba Central Hospital has been opened to start enrolment on&#xD;
      October 17th, 2017 in order for the project to be completed in December 2019.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">January 22, 2019</completion_date>
  <primary_completion_date type="Actual">January 22, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>In-hospital mortality in children 1 month to 5 years old</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>24 hours mortality in children 1 month to 5 years old</measure>
    <time_frame>24 hours after admission</time_frame>
    <description>Mortality within the first 24 hrs after admission</description>
  </secondary_outcome>
  <other_outcome>
    <measure>In-hospital mortality in children 5-12 years old</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>In hospital mortality in children with initial hypoglycaemia (blood glucose &lt;2.5mmol/l) and low glycemia after first dextrose bolus</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>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</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">410</enrollment>
  <condition>Hypoglycemia Non Diabetics</condition>
  <condition>Emergencies</condition>
  <condition>Pediatric ALL</condition>
  <condition>Critical Illness</condition>
  <arm_group>
    <arm_group_label>Dextrose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>10% dextrose</intervention_name>
    <description>Bolus of 10% dextrose 5mls/kg</description>
    <arm_group_label>Dextrose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between one month to 5 years (5 to 12 years for outcome measure no 3)&#xD;
&#xD;
          -  Parent/carer willing and able to give consent&#xD;
&#xD;
          -  Presence of one or several emergency signs (as defined in WHO pocket book of hospital&#xD;
             care for children)&#xD;
&#xD;
               -  Obstructed or absent breathing&#xD;
&#xD;
               -  Central cyanosis&#xD;
&#xD;
               -  Severe respiratory distress&#xD;
&#xD;
               -  Shock/impaired perfusion&#xD;
&#xD;
               -  Coma/reduced consciousness&#xD;
&#xD;
               -  Convulsions&#xD;
&#xD;
               -  Severe dehydration&#xD;
&#xD;
          -  Clinical concern that the child is in an emergency state&#xD;
&#xD;
          -  Blood glucose 2.5-5.0mmol/l at arrival to the emergency department (3.0-5.0mmol/l for&#xD;
             severely malnourished children). For outcome measure no 4 children with &lt;2.5 mmol/l on&#xD;
             arrival who then have 2.5-5.0 mmol/l on the repeat test 30 minutes later are also&#xD;
             included&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children with a known diagnosis of diabetes&#xD;
&#xD;
          -  Refusal to participate by the child or guardians&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Helena Hildenwall, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska Institutet</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tim Baker, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska Institutet</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Queen Dube, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>College of Medicine, Malawi</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Josephine Langton, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>College of Medicine, Malawi</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Queen Elisabeth Central Hospital</name>
      <address>
        <city>Blantyre</city>
        <country>Malawi</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zomba Central Hospital</name>
      <address>
        <city>Zomba</city>
        <country>Malawi</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Malawi</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <last_update_submitted>February 14, 2019</last_update_submitted>
  <last_update_submitted_qc>February 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Helena Hildenwall</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>pediatric</keyword>
  <keyword>critical illness</keyword>
  <keyword>Malawi</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypoglycemia</mesh_term>
    <mesh_term>Emergencies</mesh_term>
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02989675
org study id: P.01/16/1852
nct id: NCT02989675
lead sponsor: 
collaborator: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: In-hospital mortality in children 1 month to 5 years old
time frame: Up to 12 months
description: 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
measure: 24 hours mortality in children 1 month to 5 years old
time frame: 24 hours after admission
description: Mortality within the first 24 hrs after admission
measure: In-hospital mortality in children 5-12 years old
time frame: Up to 12 months
description: 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
measure: 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
description: 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
arm group label: Dextrose
arm group type: Experimental
description: 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.
arm group label: Control
arm group type: No Intervention
description: 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.
intervention type: Drug
intervention name: 10% dextrose
description: Bolus of 10% dextrose 5mls/kg
arm group label: Dextrose
criteria: 
gender: All
minimum age: 1 Month
maximum age: 12 Years
healthy volunteers: No
last name: Helena Hildenwall, MD, PhD
role: Principal Investigator
affiliation: Karolinska Institutet
last name: Tim Baker, MD, PhD
role: Principal Investigator
affiliation: Karolinska Institutet
last name: Queen Dube, MD, PhD
role: Principal Investigator
affiliation: College of Medicine, Malawi
last name: Josephine Langton, MD
role: Principal Investigator
affiliation: College of Medicine, Malawi
facility: 
facility: 
country: Malawi
responsible party type: Sponsor-Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Helena Hildenwall
investigator title: MD, PhD
mesh term: Hypoglycemia
mesh term: Emergencies
mesh term: Critical Illness