<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/NCT02994316</url>
  </required_header>
  <id_info>
    <org_study_id>9649</org_study_id>
    <nct_id>NCT02994316</nct_id>
  </id_info>
  <brief_title>Plasma Copeptin Levels in Children With Diabetic Ketoacidosis</brief_title>
  <acronym>COPACD</acronym>
  <official_title>Interest of Plasma Copeptin Levels in Management of Children With Diabetic Ketoacidosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Montpellier</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Children with diabetic ketoacidosis risk neurological complications such as cerebral edema&#xD;
      with high morbidity. To prevent cerebral edema, it is essential to control correction of&#xD;
      hypovolemia, hyperglycemia and natremia. Markers usually used in management of diabetic&#xD;
      ketoacidosis don't always permit an optimal care.&#xD;
&#xD;
      Plasma copeptin levels reflect vasopressin secretion which is high in diabetic ketoacidosis.&#xD;
&#xD;
      Therefore, monitoring of plasma copeptin levels could be of interest in children with&#xD;
      diabetic ketoacidosis and risk of sévère neurological complications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Biological risk factors for severe complications in diabetic ketoacidosis are described (high&#xD;
      blood glucose level, metabolic acidosis, high blood urea nitrogen, hypernatremia) but their&#xD;
      dosage and monitoring are not sufficient to distinguish high risks situations.&#xD;
&#xD;
      Several studies suggest that vasopressin secretion is increased in diabetic ketoacidosis.&#xD;
      This high level could be important in occurrence of cerebral edema. Monitoring of vasopressin&#xD;
      levels could then have an interest in patients at risk of severe complications but&#xD;
      reliability of copeptin dosage depend of collection conditions and its packaging. These&#xD;
      conditions are difficult to ensure and copeptin dosage, which represent vasopressin&#xD;
      secretion, is easier to perform.&#xD;
&#xD;
      Copeptin dosage could then be a new biological marker, more accurate and specific, for an&#xD;
      optimal management of diabetic ketoacidosis.&#xD;
&#xD;
      This type of study has never been carried out neither in children nor in adults.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 3, 2016</start_date>
  <completion_date type="Actual">November 25, 2018</completion_date>
  <primary_completion_date type="Actual">November 23, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Interest of copeptin dosage as a severity marker in children under the age of 16 with diabatic ketoacidosis</measure>
    <time_frame>36 hours</time_frame>
    <description>Study of correlation between copeptin levels and metabolic acidosis management of diabatic ketoacidosis in children</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation between plasma copeptin levels and other markers used in management of diabatic ketoacidosis in the first 36 hours after diagnosis- Plasma copeptin levels at diagnosis of diabate mellitus type 1 without ketoacidosis in children</measure>
    <time_frame>36 hours</time_frame>
    <description>Interest of copeptin dosage as a new marker of diabatic ketoacidosis severy compared to other used markers</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">58</enrollment>
  <condition>Diabetic Ketoacidosis Children</condition>
  <arm_group>
    <arm_group_label>children under the age of 16 diabete with ketoacidosis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>At diagnosis mellitus type 1 (measure of blood glucose level) bicarbonate levels will be measured and children will included in the arm &quot;with ketoacidosis (bicarbonate &lt; 15mmol/L)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>children under the age of 16 diabete without ketoacidosis</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>At diagnosis mellitus type 1 (measure of blood glucose level) bicarbonate levels will be measured and children will included in the arm &quot;without ketoacodosis (bicarbonate&gt; 15 mmol/L)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Copeptine dosage in children with diabetic ketoacidosis at diagnosis</intervention_name>
    <description>Blood collection of 3 mL for copeptin dosage will be taken at different times in the first hours of management of diabetic ketoacodosis in children under the age of 16 years</description>
    <arm_group_label>children under the age of 16 diabete with ketoacidosis</arm_group_label>
    <arm_group_label>children under the age of 16 diabete without ketoacidosis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Children between 6 months and 16 years&#xD;
&#xD;
          -  Diagnosis of diabetes mellitus type 1 (cardinal syndrome, blood glucose level &gt; 7&#xD;
             mmol/L in the fasted state or &gt; 11 mmol/L not in fasted state, no signs for another&#xD;
             type of diabetes mellitus)&#xD;
&#xD;
          -  Children who need an exclusive intravenous rehydration for 36 hours&#xD;
&#xD;
          -  Written informed consent of legal representative and of the child if possible&#xD;
&#xD;
          -  Beneficiary of State Social Insurance&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Child under the age of 6 months or older than 16 years&#xD;
&#xD;
          -  Non exclusive intravenous réhydration for at least 36 hours&#xD;
&#xD;
          -  Child moved from another institution and for whom an intravenous rehydration or&#xD;
             insulin therapy have already begun&#xD;
&#xD;
          -  Non type 1 diabetes mellitus&#xD;
&#xD;
          -  Non affiliation to State Social Insurance&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GILLES GC CAMBONIE, PU PH</last_name>
    <role>Study Director</role>
    <affiliation>University Hospital, Montpellier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University hospital Montpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>October 30, 2019</last_update_submitted>
  <last_update_submitted_qc>October 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 31, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ketosis</mesh_term>
    <mesh_term>Acidosis</mesh_term>
    <mesh_term>Diabetic Ketoacidosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02994316
org study id: 9649
nct id: NCT02994316
lead sponsor: 
has dmc: No
Children with diabetic ketoacidosis risk neurological complications such as cerebral edema
      with high morbidity. To prevent cerebral edema, it is essential to control correction of
      hypovolemia, hyperglycemia and natremia. Markers usually used in management of diabetic
      ketoacidosis don't always permit an optimal care.

      Plasma copeptin levels reflect vasopressin secretion which is high in diabetic ketoacidosis.

      Therefore, monitoring of plasma copeptin levels could be of interest in children with
      diabetic ketoacidosis and risk of sévère neurological complications.
Biological risk factors for severe complications in diabetic ketoacidosis are described (high
      blood glucose level, metabolic acidosis, high blood urea nitrogen, hypernatremia) but their
      dosage and monitoring are not sufficient to distinguish high risks situations.

      Several studies suggest that vasopressin secretion is increased in diabetic ketoacidosis.
      This high level could be important in occurrence of cerebral edema. Monitoring of vasopressin
      levels could then have an interest in patients at risk of severe complications but
      reliability of copeptin dosage depend of collection conditions and its packaging. These
      conditions are difficult to ensure and copeptin dosage, which represent vasopressin
      secretion, is easier to perform.

      Copeptin dosage could then be a new biological marker, more accurate and specific, for an
      optimal management of diabetic ketoacidosis.

      This type of study has never been carried out neither in children nor in adults.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Interest of copeptin dosage as a severity marker in children under the age of 16 with diabatic ketoacidosis
time frame: 36 hours
description: Study of correlation between copeptin levels and metabolic acidosis management of diabatic ketoacidosis in children
measure: Correlation between plasma copeptin levels and other markers used in management of diabatic ketoacidosis in the first 36 hours after diagnosis- Plasma copeptin levels at diagnosis of diabate mellitus type 1 without ketoacidosis in children
time frame: 36 hours
description: Interest of copeptin dosage as a new marker of diabatic ketoacidosis severy compared to other used markers
arm group label: children under the age of 16 diabete with ketoacidosis
arm group type: Experimental
description: At diagnosis mellitus type 1 (measure of blood glucose level) bicarbonate levels will be measured and children will included in the arm "with ketoacidosis (bicarbonate < 15mmol/L)
arm group label: children under the age of 16 diabete without ketoacidosis
arm group type: Sham Comparator
description: At diagnosis mellitus type 1 (measure of blood glucose level) bicarbonate levels will be measured and children will included in the arm "without ketoacodosis (bicarbonate> 15 mmol/L)
intervention type: Other
intervention name: Copeptine dosage in children with diabetic ketoacidosis at diagnosis
description: Blood collection of 3 mL for copeptin dosage will be taken at different times in the first hours of management of diabetic ketoacodosis in children under the age of 16 years
arm group label: children under the age of 16 diabete with ketoacidosis
arm group label: children under the age of 16 diabete without ketoacidosis
criteria: 
gender: All
minimum age: 6 Months
maximum age: 16 Years
healthy volunteers: Accepts Healthy Volunteers
last name: GILLES GC CAMBONIE, PU PH
role: Study Director
affiliation: University Hospital, Montpellier
facility: 
country: France
responsible party type: Sponsor
mesh term: Ketosis
mesh term: Acidosis
mesh term: Diabetic Ketoacidosis
sharing ipd: No