<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/NCT02201134</url>
  </required_header>
  <id_info>
    <org_study_id>CHU-0199</org_study_id>
    <secondary_id>2014-001196-31</secondary_id>
    <nct_id>NCT02201134</nct_id>
  </id_info>
  <brief_title>SEVOflurane Inhalation in CARdiac Arrest Resuscitated Patients Treated With Therapeutic Hypothermia</brief_title>
  <acronym>SEVOCAR</acronym>
  <official_title>SEVOflurane Inhalation in CARdiac Arrest Resuscitated Patients Treated With Therapeutic Hypothermia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Clermont-Ferrand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospital, Estaing</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hopital Gabriel Montpied</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Clermont-Ferrand</source>
  <brief_summary>
    <textblock>
      Studying the feasibility of an initial sedation with inhalated sevoflurane during therapeutic&#xD;
      hypothermia of cardiac arrests resuscitated patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective clinical study in ICU with ventilated patients sedated with sevoflurane using the&#xD;
      Mirus® and Anaconda® , establishing the feasibility of an initial sedation of patients&#xD;
      resuscitated from cardiac arrest and treated with therapeutic hypothermia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">December 2016</completion_date>
  <primary_completion_date type="Anticipated">December 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Determination of the feasibility of a sedation with inhalated sevoflurane in cardiac arrest resuscitated patients</measure>
    <time_frame>at day 1</time_frame>
    <description>The feasibility is evaluated by the number of side effects due to treatment until discharge from hospital.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Determination of neurological prognostic of patients at ICU and hospital discharge</measure>
    <time_frame>at day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determination of systemic complications and organ failures during hospitalisation</measure>
    <time_frame>at day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of systemic inflammation and evolution with cytokines</measure>
    <time_frame>at day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of markers specific of brain ischemia (S100 protein and neuron-specific enolase)</measure>
    <time_frame>at day 1</time_frame>
    <description>at 3 times: before starting sevoflurane sedation, 24 hours, 48 hours and 72 hours after starting sevoflurane sedation.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">18</enrollment>
  <condition>Cardiac Arrest</condition>
  <condition>Therapeutic Hypothermia</condition>
  <arm_group>
    <arm_group_label>sevoflurane</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>sevoflurane</intervention_name>
    <arm_group_label>sevoflurane</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  -Adult patients ventilated requiring therapeutic hypothermia in ICU&#xD;
&#xD;
          -  Stable respiratory and hemodynamic conditions&#xD;
&#xD;
          -  Epinephrine and norepinephrine infusion rate &lt; 1,5 g/kg/min&#xD;
&#xD;
          -  Consent of patients or family&#xD;
&#xD;
          -  Arterial line&#xD;
&#xD;
          -  Patients resuscitated after cardiac arrest&#xD;
&#xD;
          -  No Flow &lt; 10 min&#xD;
&#xD;
          -  Low Flow &lt; 20 min&#xD;
&#xD;
          -  Neutropenia &lt; 1 G/L&#xD;
&#xD;
          -  Post traumatic cardiac arrest&#xD;
&#xD;
          -  Contraindication of halogenated anesthesics&#xD;
&#xD;
          -  Extra corporeal life support or intra aortic balloon pump&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  -Pregnant woman&#xD;
&#xD;
          -  Hemodynamic instability&#xD;
&#xD;
          -  Brain death defined by the disappearance of brain stem reflexes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sébastien PERBET</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Clermont-Ferrand</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Patrick LACARIN</last_name>
    <phone>04 73 75 11 95</phone>
    <email>placarin@chu-clermontferrand.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU de Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patrick LACARIN</last_name>
      <phone>04 73 75 11 95</phone>
      <email>placarin@chu-clermontferrand.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>July 28, 2016</last_update_submitted>
  <last_update_submitted_qc>July 28, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cardiac arrest</keyword>
  <keyword>Therapeutic hypothermia</keyword>
  <keyword>Sevoflurane</keyword>
  <keyword>Sedation</keyword>
  <keyword>Patient resuscitated from cardiac arrest</keyword>
  <keyword>Requiring sedation</keyword>
  <keyword>Adult patients</keyword>
  <keyword>Patient covered by french health care system</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Arrest</mesh_term>
    <mesh_term>Hypothermia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sevoflurane</mesh_term>
  </intervention_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/NCT02201134
org study id: CHU-0199
secondary id: 2014-001196-31
nct id: NCT02201134
lead sponsor: 
collaborator: 
collaborator: 
Studying the feasibility of an initial sedation with inhalated sevoflurane during therapeutic
      hypothermia of cardiac arrests resuscitated patients.
Prospective clinical study in ICU with ventilated patients sedated with sevoflurane using the
      Mirus® and Anaconda® , establishing the feasibility of an initial sedation of patients
      resuscitated from cardiac arrest and treated with therapeutic hypothermia.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Determination of the feasibility of a sedation with inhalated sevoflurane in cardiac arrest resuscitated patients
time frame: at day 1
description: The feasibility is evaluated by the number of side effects due to treatment until discharge from hospital.
measure: Determination of neurological prognostic of patients at ICU and hospital discharge
time frame: at day 1
measure: Determination of systemic complications and organ failures during hospitalisation
time frame: at day 1
measure: Evaluation of systemic inflammation and evolution with cytokines
time frame: at day 1
measure: Evaluation of markers specific of brain ischemia (S100 protein and neuron-specific enolase)
time frame: at day 1
description: at 3 times: before starting sevoflurane sedation, 24 hours, 48 hours and 72 hours after starting sevoflurane sedation.
arm group label: sevoflurane
arm group type: Other
intervention type: Drug
intervention name: sevoflurane
arm group label: sevoflurane
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Sébastien PERBET
role: Principal Investigator
affiliation: University Hospital, Clermont-Ferrand
last name: Patrick LACARIN
phone: 04 73 75 11 95
email: placarin@chu-clermontferrand.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Heart Arrest
mesh term: Hypothermia
mesh term: Sevoflurane