<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/NCT02254642</url>
  </required_header>
  <id_info>
    <org_study_id>5831</org_study_id>
    <nct_id>NCT02254642</nct_id>
  </id_info>
  <brief_title>Effects of Ischemic Preconditioning After Aortic Clamping</brief_title>
  <official_title>Protective Effects of Ischemic Preconditioning on Cardiac, Renal, Pulmonary and Muscular Functions After Aortic Clamping</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Open surgery for aneurysmal aortic disease can lead to cardiac, renal, pulmonary or muscular&#xD;
      complications, essentially due to the aortic clamping. Ischemic preconditioning can be useful&#xD;
      in order to decrease these complications. The investigators would like to use an ischemic&#xD;
      preconditioning protocol during open surgery of aortic aneurysm in order to decrease these&#xD;
      complications.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    recruitment difficulties&#xD;
  </why_stopped>
  <start_date type="Actual">November 20, 2018</start_date>
  <completion_date type="Actual">December 15, 2021</completion_date>
  <primary_completion_date type="Actual">December 15, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Myocardial damage measured by troponin level &gt; 0.4 microgr/L (day 1)</measure>
    <time_frame>Day 1</time_frame>
    <description>Myocardial damage measured by Troponin I level &gt; 0.4 microg/L</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Renal damage</measure>
    <time_frame>Day 0, day 1, day 3 or day 5.</time_frame>
    <description>Renal damage measured with Post-operative Creatinin clearance &lt; 50% of Pre-operative creatinin clearance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle weakness</measure>
    <time_frame>Day 0, day 1, day 3 or day 5</time_frame>
    <description>Muscle weakness measured by Creatine phospho Kinase &gt; 200 UI/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Myocardial damage measured by troponin level &gt; 0.4 microgr/L</measure>
    <time_frame>Day 0, 3, or 5</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">59</enrollment>
  <condition>Vascular Surgery</condition>
  <condition>Ischemia-reperfusion</condition>
  <condition>Ischemia Preconditioning</condition>
  <arm_group>
    <arm_group_label>Ischemic preconditioning arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will have the ischemic preconditioning protocol 1 hour before the aortic clamping.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control patients</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Usual surgery assigned to control patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ischemic preconditioning during aortic clamping</intervention_name>
    <description>Ischemic preconditioning during aortic clamping</description>
    <arm_group_label>Ischemic preconditioning arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Procedure/Surgery: usual surgery</intervention_name>
    <description>Procedure/Surgery: usual surgery</description>
    <arm_group_label>Control patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Patients with an aortic aneurysm requiring open surgery (with no possibility of&#xD;
             endovascular surgery)&#xD;
&#xD;
          -  Patients who received clear information, with signed consent&#xD;
&#xD;
          -  Patients 18 to 85 years&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Patients under guardianship&#xD;
&#xD;
          -  No possibility to give the patients clear information (comprehension difficulties,&#xD;
             emergency surgery)&#xD;
&#xD;
          -  Pregnancy, lactation&#xD;
&#xD;
          -  Hemodialysis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anne Lejay, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôpitaux Universitaires de Strasbourg</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Service de Chirurgie Vasculaire, CH Jean Minjoz</name>
      <address>
        <city>Besancon</city>
        <zip>25030</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de Chirurgie Vasculaire, CHU le Bocage</name>
      <address>
        <city>Dijon</city>
        <zip>21079</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de Chirurgie vasculaire et transplantation rénale, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg</name>
      <address>
        <city>Strasbourg</city>
        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de Chirurgie Vasculaire, Hôpitaux Privés de Metz, Site de Mercy</name>
      <address>
        <city>Vantoux</city>
        <zip>57070</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>June 26, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <last_update_submitted>April 19, 2022</last_update_submitted>
  <last_update_submitted_qc>April 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2022</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>Ischemia</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/NCT02254642
org study id: 5831
nct id: NCT02254642
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Open surgery for aneurysmal aortic disease can lead to cardiac, renal, pulmonary or muscular
      complications, essentially due to the aortic clamping. Ischemic preconditioning can be useful
      in order to decrease these complications. The investigators would like to use an ischemic
      preconditioning protocol during open surgery of aortic aneurysm in order to decrease these
      complications.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Myocardial damage measured by troponin level > 0.4 microgr/L (day 1)
time frame: Day 1
description: Myocardial damage measured by Troponin I level > 0.4 microg/L
measure: Renal damage
time frame: Day 0, day 1, day 3 or day 5.
description: Renal damage measured with Post-operative Creatinin clearance < 50% of Pre-operative creatinin clearance
measure: Muscle weakness
time frame: Day 0, day 1, day 3 or day 5
description: Muscle weakness measured by Creatine phospho Kinase > 200 UI/L
measure: Myocardial damage measured by troponin level > 0.4 microgr/L
time frame: Day 0, 3, or 5
arm group label: Ischemic preconditioning arm
arm group type: Experimental
description: Patients will have the ischemic preconditioning protocol 1 hour before the aortic clamping.
arm group label: Control patients
arm group type: Other
description: Usual surgery assigned to control patients
intervention type: Procedure
intervention name: Ischemic preconditioning during aortic clamping
description: Ischemic preconditioning during aortic clamping
arm group label: Ischemic preconditioning arm
intervention type: Procedure
intervention name: Procedure/Surgery: usual surgery
description: Procedure/Surgery: usual surgery
arm group label: Control patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Anne Lejay, MD
role: Principal Investigator
affiliation: Hôpitaux Universitaires de Strasbourg
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Ischemia