<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/NCT01723930</url>
  </required_header>
  <id_info>
    <org_study_id>5328</org_study_id>
    <nct_id>NCT01723930</nct_id>
  </id_info>
  <brief_title>Transpulmonary Gradient After Cardiac Surgery Under Cardiopulmonary Bypass</brief_title>
  <official_title>Transpulmonary Gradient of Inflammation Biomarkers and Pulmonary Vascular Resistance in Acute Respiratory Failure After Cardiac Surgery Under Cardiopulmonary Bypass</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Strasbourg, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Strasbourg, France</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Get a better understanding of the pathophysiological processes of acute respiratory failure&#xD;
      following cardiopulmonary bypass to initiate timely therapies targeted on a cell line.&#xD;
&#xD;
      Demonstrate that there is a relationship between increased transpulmonary gradients of&#xD;
      inflammation biomarkers (sRAGE, sICAM-1, SPB, PAI-1, ROS) and pulmonary vascular resistance&#xD;
      on the one hand and alveolo-capillary gas exchange on the other hand after cardiac surgery&#xD;
      under cardiopulmonary bypass.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <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>transpulmonary gradients of inflammation biomarkers (sRAGE, sICAM-1, SPB, PAI-1, ROS) and pulmonary vascular resistance</measure>
    <time_frame>during the surgery</time_frame>
    <description>Demonstrate that there is a relationship between increased transpulmonary gradients of inflammation biomarkers (sRAGE, sICAM-1, SPB, PAI-1, ROS) and pulmonary vascular resistance on the one hand and alveolo-capillary gas exchange on the other hand after cardiac surgery under cardiopulmonary bypass.</description>
  </primary_outcome>
  <enrollment>30</enrollment>
  <condition>Acute Respiratory Distress Syndrome After Cardiac Surgery Under Cardiopulmonary Bypass</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Recruitment concerns only patients with high risk of postoperative respiratory failure&#xD;
        (SLIP score &gt; 22).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient man or woman &gt; 18 y.o.&#xD;
&#xD;
          -  Patient has signed informed consent prior to the study&#xD;
&#xD;
          -  Patient affiliated to a social security administration&#xD;
&#xD;
          -  Patient operated on for cardiac surgery at the University Hospital of Strasbourg.&#xD;
&#xD;
          -  Patient at high risk for postoperative respiratory failure defined by a SLIP score&#xD;
             (Kor et al.) ≥ 22 Kor:&#xD;
&#xD;
               -  High-risk cardiac intervention under cardiopulmonary bypass (19 pts)&#xD;
&#xD;
               -  COPD (10 pts)&#xD;
&#xD;
               -  Diabetes (6 pts)&#xD;
&#xD;
               -  gastroesophageal reflux (7 pts)&#xD;
&#xD;
               -  Alcohol abuse (11 pts)&#xD;
&#xD;
          -  Scheduled use of a pulmonary artery catheter and a left atrial catheter&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to obtain informed consent from the patient and / or unable to give informed&#xD;
             patient information (difficulty understanding ...)&#xD;
&#xD;
          -  Urgent surgery (&lt;24h)&#xD;
&#xD;
          -  Acute heart failure&#xD;
&#xD;
          -  Patient ventilated preoperatively&#xD;
&#xD;
          -  Allergy to Latex&#xD;
&#xD;
          -  Persons deprived of liberty or under judicial protection&#xD;
&#xD;
          -  Patient placed under guardianship&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Breastfeeding&#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_contact>
    <last_name>Julien POTTECHER, MD</last_name>
    <phone>03 88 12 70 95</phone>
    <email>julien.pottecher@chru-strasbourg.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>University Hospital</name>
      <address>
        <city>Strasbourg</city>
        <state>Alsace</state>
        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
    <investigator>
      <last_name>Julien POTTECHER, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mircea Cristinar, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ghaib Ajob, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Anne Roche, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Matthieu Zappaterra, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Adrien Thibaud, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Wim Skibba, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jean-Claude Thiranos, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>François Levy, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Olivier Collange, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sandrine Marguerite, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jean-Paul Schmitt, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Hubert Gros, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Anne-Lise Maechel, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Paul-Michel Mertes, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Giedrius Laurinenas, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Amir Samet, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Cécile Gros, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Annick Steib, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Pierre Diemunsch, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Michel Kindo, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jean-Philippe Mazzucotelli, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Matthieu Canuet, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Max Guillot, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Vincent Castelain, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Bernard Geny, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 6, 2012</study_first_submitted>
  <study_first_submitted_qc>November 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 8, 2012</study_first_posted>
  <last_update_submitted>November 7, 2012</last_update_submitted>
  <last_update_submitted_qc>November 7, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 8, 2012</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>
  </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/NCT01723930
org study id: 5328
nct id: NCT01723930
lead sponsor: 
has dmc: No
Get a better understanding of the pathophysiological processes of acute respiratory failure
      following cardiopulmonary bypass to initiate timely therapies targeted on a cell line.

      Demonstrate that there is a relationship between increased transpulmonary gradients of
      inflammation biomarkers (sRAGE, sICAM-1, SPB, PAI-1, ROS) and pulmonary vascular resistance
      on the one hand and alveolo-capillary gas exchange on the other hand after cardiac surgery
      under cardiopulmonary bypass.
observational model: Cohort
time perspective: Prospective
measure: transpulmonary gradients of inflammation biomarkers (sRAGE, sICAM-1, SPB, PAI-1, ROS) and pulmonary vascular resistance
time frame: during the surgery
description: Demonstrate that there is a relationship between increased transpulmonary gradients of inflammation biomarkers (sRAGE, sICAM-1, SPB, PAI-1, ROS) and pulmonary vascular resistance on the one hand and alveolo-capillary gas exchange on the other hand after cardiac surgery under cardiopulmonary bypass.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Julien POTTECHER, MD
phone: 03 88 12 70 95
email: julien.pottecher@chru-strasbourg.fr
facility: 
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country: France
responsible party type: Sponsor
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Acute Lung Injury