<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/NCT01701557</url>
  </required_header>
  <id_info>
    <org_study_id>06-0846</org_study_id>
    <nct_id>NCT01701557</nct_id>
  </id_info>
  <brief_title>Fluid Resuscitation for Pediatric Diabetic Ketoacidosis</brief_title>
  <official_title>Fluid Resuscitation for Pediatric Diabetic Ketoacidosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Randomized trial to determine if the volume of fluid administration in pediatric patients&#xD;
      with DKA impacts the rate of normalization of serum bicarbonate, pH as well as the length of&#xD;
      treatment&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized trial of two initial volumes of IVF and subsequent administration rates. Group I&#xD;
      received 10 mL/kg of NS intravenous bolus over the first hour followed by ¾ NS with potassium&#xD;
      replacement at 1.25 times maintenance and Group II received 20 mL/kg of NS intravenous bolus&#xD;
      over the first hour followed by ¾ NS with potassium replacement at 1.5 times maintenance. The&#xD;
      specific variables measured included demographics (age, gender, and race/ethnicity) and&#xD;
      routine laboratory values (pH, pCO2, plasma glucose, electrolytes, bicarbonate, sodium,&#xD;
      chloride, BUN. Length of treatment was defined as a time of the hospital stay after the start&#xD;
      of IVF infusion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2007</start_date>
  <completion_date type="Actual">June 2010</completion_date>
  <primary_completion_date type="Actual">June 2010</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>time to normalization of bicarbonate and pH</measure>
    <time_frame>start of treatment until resolution of DKA an expected average of 12 to 24 hours</time_frame>
    <description>Laboratory parameters were measured hourly for the first 4 hours, and every 2 to3 hours thereafter until acid-base normalization (pH was above 7.3 or the HCO3 was above 15 mmol/L)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the length of treatment</measure>
    <time_frame>discharge from the hospital, an expected average of 1-2 days</time_frame>
    <description>Length of treatment was defined as a time of the hospital stay after the start of IVF infusion</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Diabetes</condition>
  <arm_group>
    <arm_group_label>slow fluid rate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>bolus 10 ml/kg of NS followed by 1.25 times maintenance rate</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fast fluid rate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>bolus 20 ml/kg of NS followed by 1.5 times maintenance rate</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>slow fluid rate</intervention_name>
    <description>10 mL/kg of NS intravenous bolus over the first hour followed by ¾ NS with potassium replacement at 1.25 times maintenance</description>
    <arm_group_label>slow fluid rate</arm_group_label>
    <other_name>normal saline</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>fast fluid rate</intervention_name>
    <description>20 mL/kg of NS intravenous bolus over the first hour followed by ¾ NS with potassium replacement at 1.5 times maintenance</description>
    <arm_group_label>Fast fluid rate</arm_group_label>
    <other_name>normal saline</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1 day to 18 years of age&#xD;
&#xD;
          -  type 1 diabetes&#xD;
&#xD;
          -  presence of DKA, as defined by glucose &gt;250 mg/dl, accumulation of ketone bodies in&#xD;
             the blood, and metabolic acidosis (venous pH &lt; 7.30 or serum bicarbonate &lt; 15 mmol/L.)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  requirement for additional fluid resuscitation for hemodynamic instability&#xD;
&#xD;
          -  weight greater than 70 kilograms&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Arleta Rewers, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>the Childrens Hospital Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 1, 2012</study_first_submitted>
  <study_first_submitted_qc>October 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 5, 2012</study_first_posted>
  <last_update_submitted>October 3, 2012</last_update_submitted>
  <last_update_submitted_qc>October 3, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 5, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ketoacidosis Fluids</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ketosis</mesh_term>
    <mesh_term>Diabetic Ketoacidosis</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/NCT01701557
org study id: 06-0846
nct id: NCT01701557
lead sponsor: 
has dmc: No
Randomized trial to determine if the volume of fluid administration in pediatric patients
      with DKA impacts the rate of normalization of serum bicarbonate, pH as well as the length of
      treatment
A randomized trial of two initial volumes of IVF and subsequent administration rates. Group I
      received 10 mL/kg of NS intravenous bolus over the first hour followed by ¾ NS with potassium
      replacement at 1.25 times maintenance and Group II received 20 mL/kg of NS intravenous bolus
      over the first hour followed by ¾ NS with potassium replacement at 1.5 times maintenance. The
      specific variables measured included demographics (age, gender, and race/ethnicity) and
      routine laboratory values (pH, pCO2, plasma glucose, electrolytes, bicarbonate, sodium,
      chloride, BUN. Length of treatment was defined as a time of the hospital stay after the start
      of IVF infusion.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: time to normalization of bicarbonate and pH
time frame: start of treatment until resolution of DKA an expected average of 12 to 24 hours
description: Laboratory parameters were measured hourly for the first 4 hours, and every 2 to3 hours thereafter until acid-base normalization (pH was above 7.3 or the HCO3 was above 15 mmol/L)
measure: the length of treatment
time frame: discharge from the hospital, an expected average of 1-2 days
description: Length of treatment was defined as a time of the hospital stay after the start of IVF infusion
arm group label: slow fluid rate
arm group type: Active Comparator
description: bolus 10 ml/kg of NS followed by 1.25 times maintenance rate
arm group label: Fast fluid rate
arm group type: Active Comparator
description: bolus 20 ml/kg of NS followed by 1.5 times maintenance rate
intervention type: Other
intervention name: slow fluid rate
description: 10 mL/kg of NS intravenous bolus over the first hour followed by ¾ NS with potassium replacement at 1.25 times maintenance
arm group label: slow fluid rate
other name: normal saline
intervention type: Other
intervention name: fast fluid rate
description: 20 mL/kg of NS intravenous bolus over the first hour followed by ¾ NS with potassium replacement at 1.5 times maintenance
arm group label: Fast fluid rate
other name: normal saline
criteria: 
gender: All
minimum age: 1 Day
maximum age: 18 Years
healthy volunteers: No
last name: Arleta Rewers, MD
role: Principal Investigator
affiliation: University of Colorado, Denver
facility: 
country: United States
responsible party type: Sponsor
mesh term: Ketosis
mesh term: Diabetic Ketoacidosis