<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/NCT03281317</url>
  </required_header>
  <id_info>
    <org_study_id>PI2017_843_0014</org_study_id>
    <nct_id>NCT03281317</nct_id>
  </id_info>
  <brief_title>Vasoplegic Syndrome in Cardiac Surgery</brief_title>
  <acronym>ISYVACC</acronym>
  <official_title>Le Syndrome vasoplégique en Post-opératoire de Chirurgie Cardiaque: étude de Construction et de Validation d'un Score prédictif (Etude ISYVACC).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire, Amiens</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire, Amiens</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>
      Vasoplasmic syndrome in cardiac surgery is one of the major postoperative complications.This&#xD;
      syndrome is characterized by persistent low blood pressure despite an optimization of preload&#xD;
      and inotropism.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 15, 2017</start_date>
  <completion_date type="Anticipated">December 15, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 15, 2020</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>Vasoplegic syndrome</measure>
    <time_frame>30 days</time_frame>
    <description>Patients suffering of vasoplegic syndrom defined by persitent arterial hypotension (MAP below70 mmHg) despite fluid rescucitation, normal or high cardiac output, and treated more than 4 hours with norepinephrine</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post operative organ failure</measure>
    <time_frame>30 days</time_frame>
    <description>every post opertaive organ failure: brain, digestive, renal, cardiac...</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arrythmia</measure>
    <time_frame>30 days</time_frame>
    <description>atrial fibrillation, ventricular tachycardia, ventricular flutter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inotropic use</measure>
    <time_frame>30 days</time_frame>
    <description>dobutamine, levosimendan, phosphodiesterase</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cardiac damage</measure>
    <time_frame>1 day</time_frame>
    <description>troponine I release</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post operative Sepsis</measure>
    <time_frame>30 days</time_frame>
    <description>postoperative sepsis: pneumonae, blood stream, mediastinis, urinary track, other</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemorrhage</measure>
    <time_frame>30 days</time_frame>
    <description>postopertaive blood loss defined by the Universal definition of perioperative bleeding</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood transfusion</measure>
    <time_frame>30 days</time_frame>
    <description>red blood cell transfusion, plaquette, plasma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU stays</measure>
    <time_frame>30 days</time_frame>
    <description>Stay at ICU until patient discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital stays</measure>
    <time_frame>30 days</time_frame>
    <description>hospital stays until patient discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death</measure>
    <time_frame>one year</time_frame>
    <description>Death of any cause</description>
  </secondary_outcome>
  <enrollment type="Anticipated">3000</enrollment>
  <condition>Vasoplegic Syndrome of Cardiac Surgery</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All consecutive cardiac surgical patients who meeet inclusion criteria with cardiopulmonary&#xD;
        bypass&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients undergoing cardiac surgery with extracorporeal circulation&#xD;
&#xD;
          -  Patients covered by a social insurance system.&#xD;
&#xD;
          -  Patients who have given oral consent to participate after full information&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cardiac graft.&#xD;
&#xD;
          -  Preoperative ECMO / ECLS.&#xD;
&#xD;
          -  Cardiac assistance.&#xD;
&#xD;
          -  Minor,&#xD;
&#xD;
          -  Patient deprived of liberty, or under safeguard of justice.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pierre Grégoire guinot.pierregregoire@chu-amiens.fr, Doctor</last_name>
    <role>Study Director</role>
    <affiliation>guinot.pierregregoire@chu-amiens.fr</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Paul Michel MERTES, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU STRASBOURG</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jean-Luc Simon Jean-Baptiste FELLAHI, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU LYON</affiliation>
  </overall_official>
  <overall_official>
    <last_name>FISCHER Marc Olivier, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Caen</affiliation>
  </overall_official>
  <overall_official>
    <last_name>GIRARD Claude, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU DIJON</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Longrois Dan, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>APHP, Paris</affiliation>
  </overall_official>
  <overall_official>
    <last_name>BESNIE Emmanuel, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU de Rouen</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Pierre Grégoire GUINOT, Doctor</last_name>
    <phone>+33 322 087 899</phone>
    <email>guinot.pierregregoire@chu-amiens.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU Amiens Picardie</name>
      <address>
        <city>Amiens</city>
        <zip>80054</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pierre-Gregoire GUINOT</last_name>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>April 30, 2018</last_update_submitted>
  <last_update_submitted_qc>April 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 1, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>vasoplegicsyndrome</keyword>
  <keyword>cardiac surgery</keyword>
  <keyword>predictive risk score</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vasoplegia</mesh_term>
    <mesh_term>Syndrome</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/NCT03281317
org study id: PI2017_843_0014
nct id: NCT03281317
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Vasoplasmic syndrome in cardiac surgery is one of the major postoperative complications.This
      syndrome is characterized by persistent low blood pressure despite an optimization of preload
      and inotropism.
observational model: Cohort
time perspective: Prospective
measure: Vasoplegic syndrome
time frame: 30 days
description: Patients suffering of vasoplegic syndrom defined by persitent arterial hypotension (MAP below70 mmHg) despite fluid rescucitation, normal or high cardiac output, and treated more than 4 hours with norepinephrine
measure: Post operative organ failure
time frame: 30 days
description: every post opertaive organ failure: brain, digestive, renal, cardiac...
measure: Arrythmia
time frame: 30 days
description: atrial fibrillation, ventricular tachycardia, ventricular flutter
measure: Inotropic use
time frame: 30 days
description: dobutamine, levosimendan, phosphodiesterase
measure: cardiac damage
time frame: 1 day
description: troponine I release
measure: Post operative Sepsis
time frame: 30 days
description: postoperative sepsis: pneumonae, blood stream, mediastinis, urinary track, other
measure: Hemorrhage
time frame: 30 days
description: postopertaive blood loss defined by the Universal definition of perioperative bleeding
measure: Blood transfusion
time frame: 30 days
description: red blood cell transfusion, plaquette, plasma
measure: ICU stays
time frame: 30 days
description: Stay at ICU until patient discharge
measure: Hospital stays
time frame: 30 days
description: hospital stays until patient discharge
measure: Death
time frame: one year
description: Death of any cause
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Pierre Grégoire guinot.pierregregoire@chu-amiens.fr, Doctor
role: Study Director
affiliation: guinot.pierregregoire@chu-amiens.fr
last name: Paul Michel MERTES, Professor
role: Principal Investigator
affiliation: CHU STRASBOURG
last name: Jean-Luc Simon Jean-Baptiste FELLAHI, Professor
role: Principal Investigator
affiliation: CHU LYON
last name: FISCHER Marc Olivier, Professor
role: Principal Investigator
affiliation: University Hospital, Caen
last name: GIRARD Claude, Professor
role: Principal Investigator
affiliation: CHU DIJON
last name: Longrois Dan, Doctor
role: Principal Investigator
affiliation: APHP, Paris
last name: BESNIE Emmanuel, Doctor
role: Principal Investigator
affiliation: CHU de Rouen
last name: Pierre Grégoire GUINOT, Doctor
phone: +33 322 087 899
email: guinot.pierregregoire@chu-amiens.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Vasoplegia
mesh term: Syndrome