<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/NCT02199275</url>
  </required_header>
  <id_info>
    <org_study_id>P/2013/174</org_study_id>
    <nct_id>NCT02199275</nct_id>
  </id_info>
  <brief_title>Effect of General Anesthesia on Enterocyte Damage</brief_title>
  <acronym>GUT</acronym>
  <official_title>Impact of General Anesthesia on Enterocyte Damage</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Besancon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Besancon</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      During non urgent surgery, general anesthesia might induce enterocyte damage. I-FABP is a&#xD;
      performant biomarker of enterocyte damage. We aimed to study whether patient ongoing general&#xD;
      anesthesia for non-urgent surgery have an elevation of plasma I-FABP concentration.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Inclusion criteria&#xD;
&#xD;
        -  Indication of non-urgent surgery&#xD;
&#xD;
        -  General anesthesia protocol using propofol and remifentanyl&#xD;
&#xD;
        -  One half of the patients have a history of ischemic arteriopathy&#xD;
&#xD;
        -  One half of the patients have no history of ischemic arteriopathy&#xD;
&#xD;
      Exclusion criteria&#xD;
&#xD;
        -  Age &lt; 18 years old&#xD;
&#xD;
        -  Pregnant&#xD;
&#xD;
      Primary objective&#xD;
&#xD;
      Is there a significant elevation of I-FABP between the pre-anesthesic period and 11 minutes&#xD;
      after induction of general anesthesia ?&#xD;
&#xD;
      Secondary objectives&#xD;
&#xD;
        1. Is I-FABP elevation higher among patients with history of patent arteriopathy ?&#xD;
&#xD;
        2. Is I-FABP elevation higher among patients presenting with hypotension during anesthesia&#xD;
           ?&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2013</start_date>
  <completion_date type="Anticipated">August 2014</completion_date>
  <primary_completion_date type="Anticipated">August 2014</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>I-FABP elevation after induction of general anesthesia</measure>
    <time_frame>11 minutes</time_frame>
    <description>Primary measure of plasma I-FABP before induction of general anesthesia. Second measure of plasma I-FABP concentration 11 minutes after induction of general anesthesia using a protocol of propofol and remifentanyl with monitoring of bispectral index.</description>
  </primary_outcome>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Non-urgent Surgery</condition>
  <condition>General Anesthesia</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples on venous puncture&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Adults requiring non-urgent surgery, in whom a protocol of general anesthesia using&#xD;
        propofol and remifentanyl with monitoring of bispectral index is expected.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          -  Indication of non-urgent surgery&#xD;
&#xD;
          -  General anesthesia protocol using propofol and remifentanyl&#xD;
&#xD;
          -  One half of the patients have a history of ischemic arteriopathy&#xD;
&#xD;
          -  One half of the patients have no history of ischemic arteriopathy&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          -  Age &lt; 18 years old&#xD;
&#xD;
          -  Pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHRU de Besançon</name>
      <address>
        <city>Besançon</city>
        <zip>25030</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gaël Piton, MD</last_name>
      <phone>0033381668127</phone>
      <email>gpiton@chu-besancon.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>September 4, 2013</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 24, 2014</study_first_posted>
  <last_update_submitted>July 23, 2014</last_update_submitted>
  <last_update_submitted_qc>July 23, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 24, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centre Hospitalier Universitaire de Besancon</investigator_affiliation>
    <investigator_full_name>Gael PITON</investigator_full_name>
    <investigator_title>MCU-PH</investigator_title>
  </responsible_party>
  <keyword>Non-urgent surgery</keyword>
  <keyword>General anesthesia</keyword>
  <keyword>Enterocyte damage</keyword>
  <keyword>Intestinal fatty acid-binding protein</keyword>
  <!-- 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/NCT02199275
org study id: P/2013/174
nct id: NCT02199275
lead sponsor: 
has dmc: Yes
During non urgent surgery, general anesthesia might induce enterocyte damage. I-FABP is a
      performant biomarker of enterocyte damage. We aimed to study whether patient ongoing general
      anesthesia for non-urgent surgery have an elevation of plasma I-FABP concentration.
Inclusion criteria

        -  Indication of non-urgent surgery

        -  General anesthesia protocol using propofol and remifentanyl

        -  One half of the patients have a history of ischemic arteriopathy

        -  One half of the patients have no history of ischemic arteriopathy

      Exclusion criteria

        -  Age < 18 years old

        -  Pregnant

      Primary objective

      Is there a significant elevation of I-FABP between the pre-anesthesic period and 11 minutes
      after induction of general anesthesia ?

      Secondary objectives

        1. Is I-FABP elevation higher among patients with history of patent arteriopathy ?

        2. Is I-FABP elevation higher among patients presenting with hypotension during anesthesia
           ?
observational model: Case-Only
time perspective: Prospective
measure: I-FABP elevation after induction of general anesthesia
time frame: 11 minutes
description: Primary measure of plasma I-FABP before induction of general anesthesia. Second measure of plasma I-FABP concentration 11 minutes after induction of general anesthesia using a protocol of propofol and remifentanyl with monitoring of bispectral index.
Blood samples on venous puncture
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Centre Hospitalier Universitaire de Besancon
investigator full name: Gael PITON
investigator title: MCU-PH