xml: <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/NCT05984563</url>
    </required_header>
    <id_info>
      <org_study_id>2022_0705</org_study_id>
      <nct_id>NCT05984563</nct_id>
    </id_info>
    <brief_title>Optimization Strategy for Oxygen Delivery Under Cardiopulmonary Bypass</brief_title>
    <acronym>OPTI-DO2</acronym>
    <official_title>Official Title Optimization Strategy to Predict and Individualize Oxygen Delivery During Cardiac Surgery Under Cardiopulmonary Bypass</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Lille</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital, Lille</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>
        Cardiac surgery is a frequent procedure that can lead to serious complications, including&#xD;
        acute kidney injury (AKI) or postoperative delirium. During the intervention, a&#xD;
        cardiopulmonary bypass (CPB) is used to ensure tissue perfusion and oxygen delivery (DO2).&#xD;
        The hypothesisis that an individualized strategy to optimize DO2 during CPB could decrease&#xD;
        complications rate after cardiac surgery. Indeed, it is known that DO2 depends on CPB output,&#xD;
        hemoglobin level and O2 tension. To this day, a DO2 threshold below 280 mL is known to be&#xD;
        associated with postoperative AKI. From these data, a &quot;Goal Directed Perfusion&quot; strategy is&#xD;
        widely used to maintain a DO2 above this threshold during CPB. But DO2 decrease in&#xD;
        unpredictable, and the other factors influencing DO2 interindividual variability are not&#xD;
        known. Moreover, the relation between DO2 and tissue perfusion is not well established, as&#xD;
        DO2 requirement could differ between individuals or organs. Population approach using&#xD;
        nonlinear mixed models is a method used to optimize drug administration with pharmacokinetics&#xD;
        and pharmacodynamics models. Using this method, the aim of this study is to evaluate DO2&#xD;
        variability during CPB and develop a model to optimize GDP strategy.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">April 4, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 24, 2024</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>values oF D02 calculated with the CONNECT software (LivaNova, London, United Kingdom) using CPB output and hemoglobin values (measured using Spectrum Medical M4) (standard care)</measure>
      <time_frame>Every 20 to 30 seconds during CPB (standard care) and up to 28 days</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Incidence of postoperative AKI using creatinine measurement (standard care)</measure>
      <time_frame>up to 48 hours postoperative</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of postoperative deliriumassessed by CAM-ICU, CPC and mRS scores</measure>
      <time_frame>up to 48 hours postoperative</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Vital status checklist</measure>
      <time_frame>up to 28 days postoperative</time_frame>
    </secondary_outcome>
    <enrollment type="Anticipated">70</enrollment>
    <condition>Cardiac Surgery</condition>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Cardiopulmonary bypass</intervention_name>
      <description>CPB will be ensured as usual care: priming volume will be set as 1200 to 1500 mL. Patient blood management and hemodynamic management will be left at the discretion of the anesthesiologist in charge of the patient. Anticoagulation during CPB will be handled through an initial heparin bolus of 300-400 UI/kg followed by additional boluses to maintain ACT above 400 s. Non-heparin-coated bypass circuits incorporating an integrated phosphorylcholine-coated oxygenation system will be used.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients undergoing elective cardiac surgery under CPB at the university hospital of Lille,&#xD;
          France&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients aged over 18&#xD;
  &#xD;
            -  Patients scheduled for elective cardiac surgery under CPB at the university hospital&#xD;
               of Lille, France&#xD;
  &#xD;
            -  Patients with given written consent&#xD;
  &#xD;
            -  Patient insured under the French social security system&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant or breastfeeding&#xD;
  &#xD;
            -  Off pump cardiac surgery&#xD;
  &#xD;
            -  Lack of DO2 monitoring&#xD;
  &#xD;
            -  Emergency surgery (infectious endocarditis, aortic dissection, cardiac&#xD;
               transplantation, LVAD implantation) Uncontrolled sepsis&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Oxygen delivery</keyword>
    <keyword>Cardiopulmonary bypass</keyword>
    <keyword>Cardiac surgery</keyword>
    <keyword>Goal-directed perfusion</keyword>
    <keyword>Acute kidney injury</keyword>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05984563
  org study id: 2022_0705
  nct id: NCT05984563
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Cardiac surgery is a frequent procedure that can lead to serious complications, including
        acute kidney injury (AKI) or postoperative delirium. During the intervention, a
        cardiopulmonary bypass (CPB) is used to ensure tissue perfusion and oxygen delivery (DO2).
        The hypothesisis that an individualized strategy to optimize DO2 during CPB could decrease
        complications rate after cardiac surgery. Indeed, it is known that DO2 depends on CPB output,
        hemoglobin level and O2 tension. To this day, a DO2 threshold below 280 mL is known to be
        associated with postoperative AKI. From these data, a "Goal Directed Perfusion" strategy is
        widely used to maintain a DO2 above this threshold during CPB. But DO2 decrease in
        unpredictable, and the other factors influencing DO2 interindividual variability are not
        known. Moreover, the relation between DO2 and tissue perfusion is not well established, as
        DO2 requirement could differ between individuals or organs. Population approach using
        nonlinear mixed models is a method used to optimize drug administration with pharmacokinetics
        and pharmacodynamics models. Using this method, the aim of this study is to evaluate DO2
        variability during CPB and develop a model to optimize GDP strategy.
  observational model: Cohort
  time perspective: Prospective
  measure: values oF D02 calculated with the CONNECT software (LivaNova, London, United Kingdom) using CPB output and hemoglobin values (measured using Spectrum Medical M4) (standard care)
  time frame: Every 20 to 30 seconds during CPB (standard care) and up to 28 days
  measure: Incidence of postoperative AKI using creatinine measurement (standard care)
  time frame: up to 48 hours postoperative
  measure: Incidence of postoperative deliriumassessed by CAM-ICU, CPC and mRS scores
  time frame: up to 48 hours postoperative
  measure: Vital status checklist
  time frame: up to 28 days postoperative
  intervention type: Device
  intervention name: Cardiopulmonary bypass
  description: CPB will be ensured as usual care: priming volume will be set as 1200 to 1500 mL. Patient blood management and hemodynamic management will be left at the discretion of the anesthesiologist in charge of the patient. Anticoagulation during CPB will be handled through an initial heparin bolus of 300-400 UI/kg followed by additional boluses to maintain ACT above 400 s. Non-heparin-coated bypass circuits incorporating an integrated phosphorylcholine-coated oxygenation system will be used.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: No
  responsible party type: Sponsor