<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/NCT02216019</url>
  </required_header>
  <id_info>
    <org_study_id>I13015 Influx</org_study_id>
    <nct_id>NCT02216019</nct_id>
  </id_info>
  <brief_title>Diagnostic Interest of Leukocyte Immunophenotyping Using Multiparameter 8-color Flow Cytometry in Heart Surgery</brief_title>
  <acronym>INFLUX</acronym>
  <official_title>Diagnostic Interest of Leukocyte Immunophenotyping Using Multiparameter 8-color Flow Cytometry in Heart Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Limoges</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Limoges</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In septic patients, Septiflux1 study identified immature granulocytes which may have a&#xD;
      diagnostic and prognostic interest. However, with these preliminary results it is not&#xD;
      possible to make a difference between what is linked to the infection and what is a&#xD;
      consequence of the inflammation which goes along with the septic process. Using flow&#xD;
      cytometry, the study of leukocytes in a pure inflammatory model such as cardiopulmonary&#xD;
      bypass in heart surgery could make possible to test the diagnostic interest of the immature&#xD;
      granulocytes but also to attribute a prognostic value for the occurrence of post-operative&#xD;
      infections.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Expression of CD10, CD16, CD24, CD64 on granulocytes, of CD14 and CD16 on monocytes and of&#xD;
      CD3 on T lymphocytes.&#xD;
&#xD;
      Flow cytometers will all be calibrated the same way using common reagents (known fluorescent&#xD;
      calibration beads). Moreover, CD45 and CD3 level of expression on lymphocytes will help to&#xD;
      check that the collection of data is standardized between the different centers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2013</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">April 2014</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>Expression of the marker CD64, CD10 and CD16</measure>
    <time_frame>1 hour</time_frame>
    <description>Evolution rate of CD64, CD10 and CD16 in the immediate postoperative cardiac surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Early onset of infectious complications</measure>
    <time_frame>7 days</time_frame>
    <description>Early onset of infectious complications in the 7 days post-operative</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Cardiac Surgery</condition>
  <arm_group>
    <arm_group_label>study cohort</arm_group_label>
    <description>Patient undergoing planned heart surgery with cardiopulmonary bypass</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Whole blood</intervention_name>
    <description>preoparatoire whole blood and postoperative whole blood</description>
    <arm_group_label>study cohort</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      whole blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patient undergoing planned heart surgery with cardiopulmonary bypass&#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 undergoing planned heart surgery with cardiopulmonary bypass&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy,&#xD;
&#xD;
          -  progressive solid cancer,&#xD;
&#xD;
          -  HIV infection,&#xD;
&#xD;
          -  history of blood or inflammatory disease,&#xD;
&#xD;
          -  long-term immunosuppressive treatment,&#xD;
&#xD;
          -  urgent surgical intervention,&#xD;
&#xD;
          -  documented preoperative infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bruno FRANCOIS, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU LIMOGES</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU de Limoges - Service de réanimation polyvalente</name>
      <address>
        <city>Limoges</city>
        <zip>87042</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 11, 2014</study_first_submitted>
  <study_first_submitted_qc>August 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>August 13, 2014</last_update_submitted>
  <last_update_submitted_qc>August 13, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cardiac surgery</keyword>
  <keyword>infectious complication</keyword>
  <!-- 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/NCT02216019
org study id: I13015 Influx
nct id: NCT02216019
lead sponsor: 
has dmc: No
In septic patients, Septiflux1 study identified immature granulocytes which may have a
      diagnostic and prognostic interest. However, with these preliminary results it is not
      possible to make a difference between what is linked to the infection and what is a
      consequence of the inflammation which goes along with the septic process. Using flow
      cytometry, the study of leukocytes in a pure inflammatory model such as cardiopulmonary
      bypass in heart surgery could make possible to test the diagnostic interest of the immature
      granulocytes but also to attribute a prognostic value for the occurrence of post-operative
      infections.
Expression of CD10, CD16, CD24, CD64 on granulocytes, of CD14 and CD16 on monocytes and of
      CD3 on T lymphocytes.

      Flow cytometers will all be calibrated the same way using common reagents (known fluorescent
      calibration beads). Moreover, CD45 and CD3 level of expression on lymphocytes will help to
      check that the collection of data is standardized between the different centers.
observational model: Cohort
time perspective: Prospective
measure: Expression of the marker CD64, CD10 and CD16
time frame: 1 hour
description: Evolution rate of CD64, CD10 and CD16 in the immediate postoperative cardiac surgery
measure: Early onset of infectious complications
time frame: 7 days
description: Early onset of infectious complications in the 7 days post-operative
arm group label: study cohort
description: Patient undergoing planned heart surgery with cardiopulmonary bypass
intervention type: Other
intervention name: Whole blood
description: preoparatoire whole blood and postoperative whole blood
arm group label: study cohort
whole blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bruno FRANCOIS, MD
role: Principal Investigator
affiliation: CHU LIMOGES
facility: 
country: France
responsible party type: Sponsor