<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/NCT03261232</url>
  </required_header>
  <id_info>
    <org_study_id>ELLOUZE 2016 Pro-ACR</org_study_id>
    <nct_id>NCT03261232</nct_id>
  </id_info>
  <brief_title>Search for Prognostic Factors Associated With Better Survival in Refractory Cardiac Arrest</brief_title>
  <acronym>Pro-ACR</acronym>
  <official_title>Prognostic Factors in Refractory Cardiac Arrest Treated With Extracorporeal Life Support at Dijon CHU</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Dijon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Dijon</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Through this retrospective observational study (over 4 years; period analysed: 1st January&#xD;
      2011 to 31st December 2014), we looked for prognostic factors associated with better survival&#xD;
      in refractory cardiac arrest by:&#xD;
&#xD;
        -  assessing the overall survival rate&#xD;
&#xD;
        -  evaluating the frequency of intra et extra-hospital events and by comparing these with&#xD;
           the survival rate&#xD;
&#xD;
        -  studying no flow, low flow, rhythm at initial management, troponinemia, lactatemia and&#xD;
           blood pH in the different groups.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">March 2016</start_date>
  <completion_date type="Anticipated">March 2018</completion_date>
  <primary_completion_date type="Anticipated">March 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Survival rate</measure>
    <time_frame>at baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Death rate</measure>
    <time_frame>at baseline</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">65</enrollment>
  <condition>Cardiac Arrest (CA)</condition>
  <condition>ExtraCorporeal Life Support (ECLS)</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with in-hospital or out-of-hospital refractory CA who underwent ECLS&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with in-hospital or out-of-hospital refractory CA who underwent ECLS&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  CA occurring during cardiac surgery&#xD;
&#xD;
          -  Age &gt; 75 years or &lt; 18 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHU Dijon Bourgogne</name>
      <address>
        <city>Dijon</city>
        <zip>21079</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>August 23, 2017</last_update_submitted>
  <last_update_submitted_qc>August 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2017</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>Heart Arrest</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/NCT03261232
org study id: ELLOUZE 2016 Pro-ACR
nct id: NCT03261232
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Through this retrospective observational study (over 4 years; period analysed: 1st January
      2011 to 31st December 2014), we looked for prognostic factors associated with better survival
      in refractory cardiac arrest by:

        -  assessing the overall survival rate

        -  evaluating the frequency of intra et extra-hospital events and by comparing these with
           the survival rate

        -  studying no flow, low flow, rhythm at initial management, troponinemia, lactatemia and
           blood pH in the different groups.
observational model: Cohort
time perspective: Retrospective
measure: Survival rate
time frame: at baseline
measure: Death rate
time frame: at baseline
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Heart Arrest