<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/NCT02216708</url>
  </required_header>
  <id_info>
    <org_study_id>PR-11004</org_study_id>
    <nct_id>NCT02216708</nct_id>
  </id_info>
  <brief_title>Slow Versus Rapid Rehydration of Severely Malnourished Children</brief_title>
  <official_title>Comparison of Rapid and Slow Rehydration of Severely Malnourished Children Suffering From Dehydrating Diarrhoea and Impact on Renal Function and Subsequent Growth of Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>International Centre for Diarrhoeal Disease Research, Bangladesh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>International Centre for Diarrhoeal Disease Research, Bangladesh</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The recommendation for correction of dehydration of severely malnourished children with&#xD;
      diarrhoea includes oral rehydration and if parenteral rehydration is necessary (for example,&#xD;
      in severe dehydration) to infuse intravenous fluids very slowly due to the concern of heart&#xD;
      failure. There is not enough evidence to convince some of the physicians dealing with&#xD;
      severely malnourished children with dehydrating diarrhoea (for example, cholera) that rapid&#xD;
      rehydration per se is associated with increased incidence of over hydration and heart&#xD;
      failure. And whether this approach is applicable in the management of severely malnourished&#xD;
      children with severe cholera, which usually require rapid correction of water and electrolyte&#xD;
      deficits for prevention of deaths due to hypovolaemic shock and other complications, has not&#xD;
      been studied carefully. Recently, we have demonstrated that rapid intravenous rehydration&#xD;
      (within 4 to 6 hours) of severely malnourished children with dehydrating cholera replacing&#xD;
      appropriate amount of fluid was found to be safe. We feel that rapid rehydration would help&#xD;
      in improving the renal function, acidosis and thus improve appetite and reduce ORS failure&#xD;
      subsequently. Since our study was uncontrolled, so we have planned a randomised controlled&#xD;
      study with adequate sample of 250 participants; 125 will be rehydrated slowly (over 10 to 12&#xD;
      hours) following WHO guideline and 125 patients will be rehydrated with intravenous fluid&#xD;
      over 6 hours. Children of either gender, age 6 to 60 months, severely malnourished (Wt for&#xD;
      length &lt;-3 Z score of WHO growth chart or with nutritional oedema) with a history of watery&#xD;
      of &lt;24 hours with signs severe dehydration attending the ICDDRB Dhaka hospital will be asked&#xD;
      to participate in this study. After the parents'/Legal guardian's consent, the children will&#xD;
      be transferred to the study ward and will be treated according to the protocol. All children&#xD;
      will receive similar treatment except the mode of rehydration, different for the two groups.&#xD;
      The children will be closely monitored throughout the study period. The primary outcomes&#xD;
      incidence of over hydration and ORS failure and secondary outcomes improvement of renal&#xD;
      function and improvement of appetite measured by the food intake will be compared between the&#xD;
      groups.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2011</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <phase>Phase 2</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of over- hydration</measure>
    <time_frame>7 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of patient with ORS failure/ requirement of unscheduled IV therapy</measure>
    <time_frame>7 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of patient with acidosis and increased serum creatinine after 24 hours</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">208</enrollment>
  <condition>Diarrhea</condition>
  <arm_group>
    <arm_group_label>intravenous fluid for rehydration rapidly over 6 hours</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>intravenous fluid for rehydration rapidly over 6 hours</description>
  </arm_group>
  <arm_group>
    <arm_group_label>receive slow rehydration recommended by WHO (12 hours)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>receive intravenous fluid followed by ORS (slow rehydration recommended by WHO) over 12 hours</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Rapid dehydration</intervention_name>
    <arm_group_label>intravenous fluid for rehydration rapidly over 6 hours</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Slow rehydration</intervention_name>
    <arm_group_label>receive slow rehydration recommended by WHO (12 hours)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. History of acute watery diarrhoea of &lt;24 hours.&#xD;
&#xD;
          2. Either sex.&#xD;
&#xD;
          3. Severe dehydration according to WHO guidelines&#xD;
&#xD;
          4. Wt for length/wt for age &lt; -3 SD of WHO growth standard with or without&#xD;
             oedema.(malnutrition)&#xD;
&#xD;
          5. Consent given by the parents or legal guardian&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Bloody diarrhoea.&#xD;
&#xD;
          2. Severe infection (e.g. severe pneumonia, clinical sepsis, septic shock, meningitis).&#xD;
&#xD;
          3. Those who received antibiotics/antimicrobial for the current illness&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>36 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>icddr,b Dhaka Hospital</name>
      <address>
        <city>Dhaka</city>
        <country>Bangladesh</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bangladesh</country>
  </location_countries>
  <verification_date>March 2011</verification_date>
  <study_first_submitted>August 13, 2014</study_first_submitted>
  <study_first_submitted_qc>August 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>August 20, 2014</last_update_submitted>
  <last_update_submitted_qc>August 20, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 21, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Severe malnutrition</keyword>
  <keyword>severe dehydration</keyword>
  <keyword>cholera</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diarrhea</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/NCT02216708
org study id: PR-11004
nct id: NCT02216708
lead sponsor: 
has dmc: Yes
The recommendation for correction of dehydration of severely malnourished children with
      diarrhoea includes oral rehydration and if parenteral rehydration is necessary (for example,
      in severe dehydration) to infuse intravenous fluids very slowly due to the concern of heart
      failure. There is not enough evidence to convince some of the physicians dealing with
      severely malnourished children with dehydrating diarrhoea (for example, cholera) that rapid
      rehydration per se is associated with increased incidence of over hydration and heart
      failure. And whether this approach is applicable in the management of severely malnourished
      children with severe cholera, which usually require rapid correction of water and electrolyte
      deficits for prevention of deaths due to hypovolaemic shock and other complications, has not
      been studied carefully. Recently, we have demonstrated that rapid intravenous rehydration
      (within 4 to 6 hours) of severely malnourished children with dehydrating cholera replacing
      appropriate amount of fluid was found to be safe. We feel that rapid rehydration would help
      in improving the renal function, acidosis and thus improve appetite and reduce ORS failure
      subsequently. Since our study was uncontrolled, so we have planned a randomised controlled
      study with adequate sample of 250 participants; 125 will be rehydrated slowly (over 10 to 12
      hours) following WHO guideline and 125 patients will be rehydrated with intravenous fluid
      over 6 hours. Children of either gender, age 6 to 60 months, severely malnourished (Wt for
      length <-3 Z score of WHO growth chart or with nutritional oedema) with a history of watery
      of <24 hours with signs severe dehydration attending the ICDDRB Dhaka hospital will be asked
      to participate in this study. After the parents'/Legal guardian's consent, the children will
      be transferred to the study ward and will be treated according to the protocol. All children
      will receive similar treatment except the mode of rehydration, different for the two groups.
      The children will be closely monitored throughout the study period. The primary outcomes
      incidence of over hydration and ORS failure and secondary outcomes improvement of renal
      function and improvement of appetite measured by the food intake will be compared between the
      groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of over- hydration
time frame: 7 days
measure: Proportion of patient with ORS failure/ requirement of unscheduled IV therapy
time frame: 7 days
measure: Proportion of patient with acidosis and increased serum creatinine after 24 hours
time frame: 7 days
arm group label: intravenous fluid for rehydration rapidly over 6 hours
arm group type: Experimental
description: intravenous fluid for rehydration rapidly over 6 hours
arm group label: receive slow rehydration recommended by WHO (12 hours)
arm group type: Experimental
description: receive intravenous fluid followed by ORS (slow rehydration recommended by WHO) over 12 hours
intervention type: Other
intervention name: Rapid dehydration
arm group label: intravenous fluid for rehydration rapidly over 6 hours
intervention type: Other
intervention name: Slow rehydration
arm group label: receive slow rehydration recommended by WHO (12 hours)
criteria: 
gender: All
minimum age: 6 Months
maximum age: 36 Months
healthy volunteers: No
facility: 
country: Bangladesh
responsible party type: Sponsor
mesh term: Diarrhea