<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/NCT03007862</url>
  </required_header>
  <id_info>
    <org_study_id>2016-37</org_study_id>
    <nct_id>NCT03007862</nct_id>
  </id_info>
  <brief_title>Bronchial Alpha Amylase as a Marker for Early Aspiration Pneumonia in Therapeutic Hypothermia.</brief_title>
  <official_title>Salivary Alpha Amylase Bronchial Measure for Early Aspiration Pneumonia Diagnosis in Patients Treated With Therapeutic Hypothermia After Out-of-hospital Cardiac Arrest.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique Hopitaux De Marseille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique Hopitaux De Marseille</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Early Aspiration Pneumonia is a frequent and dreadful complication in survivors of cardiac&#xD;
      arrest. Therapeutic Hypothermia widely used in Intensive Care Unit for its benefice on post&#xD;
      cardiac arrest syndrome may otherwise hide signs of early pneumonia that may occur without&#xD;
      use of a reliable screening biological marker. The goal is to assess the diagnostic accuracy&#xD;
      of bronchial alpha amylase measure to predict a risk of early aspiration pneumonia in&#xD;
      patients successfully resuscitated after out-of-hospital cardiac arrest.&#xD;
&#xD;
      In this prospective non interventional study we included patients resuscitated after cardiac&#xD;
      arrest and treated with Targeted Temperature Management (TTM). A distal bronchoalveolar&#xD;
      lavage using specific display (Combi-Cath) was executed immediately after admission for each&#xD;
      patient with both biochemic and bacteriological analysis including dosage of bronchial&#xD;
      salivary alpha amylase. Urea was used as a marker of dilution in the measure of bronchial and&#xD;
      plasmatic alpha amylase. Aspiration pneumonia diagnosis was established with clinical and&#xD;
      biological criteria. On this basis we intended to determine a threshold measure of alpha&#xD;
      amylase predicting occurrence of aspiration pneumonia and allowing a guidance in&#xD;
      antibiotherapy prescription. Sensibility and Specificity of this technique were determined.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">May 2019</completion_date>
  <primary_completion_date type="Anticipated">May 2018</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Early Aspiration Pneumonia</measure>
    <time_frame>Within 5 days</time_frame>
    <description>Diagnosis of aspiration pneumonia after cardiac arrest with clinical, biological and radiological criteria including fever, leucocytes, broncho alveolar secretion, chest radiography and bacteriological identification.</description>
  </primary_outcome>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Early Aspiration Pneumonia</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Early Aspiration Pneumonia after out-of-hospital cardiac arrest treated with Therapeutic&#xD;
        Temperature Management&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Well resuscitated patients after out-of-hospital cardiac arrest&#xD;
&#xD;
          -  Indication of Therapeutic Temperature Management&#xD;
&#xD;
          -  Patients aged over 18 years&#xD;
&#xD;
          -  Immediate or deferred acceptation of study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients aged under 18 years.&#xD;
&#xD;
          -  Pregnant women.&#xD;
&#xD;
          -  Against indication to therapeutic hypothermia.&#xD;
&#xD;
          -  Active therapeutic limitation after admission.&#xD;
&#xD;
          -  Patient without social security.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Urielle Desalbres</last_name>
    <role>Study Director</role>
    <affiliation>Assistance Publique Hôpitaux de Marseille</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jeremy BOURENNE</last_name>
    <email>jeremy.bourenne@sfr.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Assistance Publique Hôpitaux de Marseille</name>
      <address>
        <city>Marseille</city>
        <zip>13005</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jeremy Bourenne</last_name>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>January 9, 2017</last_update_submitted>
  <last_update_submitted_qc>January 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 10, 2017</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>Pneumonia</mesh_term>
    <mesh_term>Pneumonia, Aspiration</mesh_term>
    <mesh_term>Hypothermia</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/NCT03007862
org study id: 2016-37
nct id: NCT03007862
lead sponsor: 
has dmc: No
Early Aspiration Pneumonia is a frequent and dreadful complication in survivors of cardiac
      arrest. Therapeutic Hypothermia widely used in Intensive Care Unit for its benefice on post
      cardiac arrest syndrome may otherwise hide signs of early pneumonia that may occur without
      use of a reliable screening biological marker. The goal is to assess the diagnostic accuracy
      of bronchial alpha amylase measure to predict a risk of early aspiration pneumonia in
      patients successfully resuscitated after out-of-hospital cardiac arrest.

      In this prospective non interventional study we included patients resuscitated after cardiac
      arrest and treated with Targeted Temperature Management (TTM). A distal bronchoalveolar
      lavage using specific display (Combi-Cath) was executed immediately after admission for each
      patient with both biochemic and bacteriological analysis including dosage of bronchial
      salivary alpha amylase. Urea was used as a marker of dilution in the measure of bronchial and
      plasmatic alpha amylase. Aspiration pneumonia diagnosis was established with clinical and
      biological criteria. On this basis we intended to determine a threshold measure of alpha
      amylase predicting occurrence of aspiration pneumonia and allowing a guidance in
      antibiotherapy prescription. Sensibility and Specificity of this technique were determined.
observational model: Case-Only
time perspective: Prospective
measure: Early Aspiration Pneumonia
time frame: Within 5 days
description: Diagnosis of aspiration pneumonia after cardiac arrest with clinical, biological and radiological criteria including fever, leucocytes, broncho alveolar secretion, chest radiography and bacteriological identification.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Urielle Desalbres
role: Study Director
affiliation: Assistance Publique Hôpitaux de Marseille
last name: Jeremy BOURENNE
email: jeremy.bourenne@sfr.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Pneumonia
mesh term: Pneumonia, Aspiration
mesh term: Hypothermia