<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/NCT03262155</url>
  </required_header>
  <id_info>
    <org_study_id>35RC16_3037_IMPECstudy</org_study_id>
    <nct_id>NCT03262155</nct_id>
  </id_info>
  <brief_title>Study of Immunity Dysfunction Induced by Extracorporeal Assistance (ECMO / ECLS)</brief_title>
  <acronym>IMPEC</acronym>
  <official_title>Study of Immunity Dysfunction Induced by Extracorporeal Assistance (ECMO / ECLS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rennes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rennes University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study of immunosuppression biomarkers in patients with ARDS or cardiogenic shock with ECMO /&#xD;
      ECLS, compared to patients with ARDS or cardiogenic shock without ECMO / ECLS&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">January 31, 2019</completion_date>
  <primary_completion_date type="Actual">January 31, 2019</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of immunosuppression in patients with ARDS or cardiogenic shock under ECMO / ECLS hospitalized in intensive care unit</measure>
    <time_frame>Hour 24</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">18</enrollment>
  <condition>Acute Respiratory Distress Syndrome</condition>
  <condition>Cardiogenic Shock</condition>
  <arm_group>
    <arm_group_label>ECMO / ECLS</arm_group_label>
    <description>Patients hospitalized for ARDS or Cardiogenic shock with ECMO / ECLS</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No ECMO / ECLS</arm_group_label>
    <description>Patients hospitalized for ARDS or Cardiogenic shock without ECMO / ECLS</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Blood test</intervention_name>
    <arm_group_label>ECMO / ECLS</arm_group_label>
    <arm_group_label>No ECMO / ECLS</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      plasma&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients hospitalized for ARDS or Cardiogenic shock with or without ECMO / ECLS&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient older than 18 years old&#xD;
&#xD;
          -  Patient hospitalized in an intensive care unit&#xD;
&#xD;
          -  Patient whose initial ARDS or Cardiogenic shock began less than 5 days before&#xD;
             admission&#xD;
&#xD;
          -  Patients hospitalized for ARDS or Cardiogenic shock with ECMO / ECLS or - Patients&#xD;
             hospitalized for ARDS or Cardiogenic shock without ECMO / ECLS&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Opposition of patient, relative or legal representative for participation in the study&#xD;
&#xD;
          -  Pregnant woman&#xD;
&#xD;
          -  Pre-immunodepression&#xD;
&#xD;
          -  Implementation of immunosuppressive therapy such as chemotherapy, cyclophosphamide,&#xD;
             high-dose corticosteroids (&gt; 0.5mg / kg / day).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHU de Rennes</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2023</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 25, 2017</study_first_posted>
  <last_update_submitted>April 11, 2023</last_update_submitted>
  <last_update_submitted_qc>April 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2023</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>Respiratory Distress Syndrome</mesh_term>
    <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term>
    <mesh_term>Acute Lung Injury</mesh_term>
    <mesh_term>Shock, Cardiogenic</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/NCT03262155
org study id: 35RC16_3037_IMPECstudy
nct id: NCT03262155
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Study of immunosuppression biomarkers in patients with ARDS or cardiogenic shock with ECMO /
      ECLS, compared to patients with ARDS or cardiogenic shock without ECMO / ECLS
observational model: Cohort
time perspective: Prospective
measure: Prevalence of immunosuppression in patients with ARDS or cardiogenic shock under ECMO / ECLS hospitalized in intensive care unit
time frame: Hour 24
arm group label: ECMO / ECLS
description: Patients hospitalized for ARDS or Cardiogenic shock with ECMO / ECLS
arm group label: No ECMO / ECLS
description: Patients hospitalized for ARDS or Cardiogenic shock without ECMO / ECLS
intervention type: Biological
intervention name: Blood test
arm group label: ECMO / ECLS
arm group label: No ECMO / ECLS
plasma
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Acute Lung Injury
mesh term: Shock, Cardiogenic
sharing ipd: No