<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/NCT02200159</url>
  </required_header>
  <id_info>
    <org_study_id>CHU-0197</org_study_id>
    <secondary_id>2013-000960-26</secondary_id>
    <nct_id>NCT02200159</nct_id>
  </id_info>
  <brief_title>Predictive Factors of Failure or Success of Sedation With Dexmedetomidine in ICU</brief_title>
  <official_title>Predictive Factors of Failure or Success of Sedation With Dexmedetomidine in ICU</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Clermont-Ferrand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Clermont-Ferrand</source>
  <brief_summary>
    <textblock>
      Research predictive factors of success or failure of a sedation with Dexmedetomidine in ICU&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective clinical study in ICU with sedated ventilated patients with dexmedetomidine,&#xD;
      establishing incidence of success, failure of moderate sedation or failure of&#xD;
      dexmedetomidine, to evaluate the effectiveness of this drug sedation in moderate sedation&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2014</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">December 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with failure of sedation with dexmedetomidine</measure>
    <time_frame>at day 1</time_frame>
    <description>Number of patients with failure of sedation with dexmedetomidine (necessity to stop this sedation due to adverse event, RASS&gt;+1, other) in ICU patients requiring such sedation during ICU stay.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse event of dexmedetomidine</measure>
    <time_frame>at day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of delirium and use of other sedative drugs</measure>
    <time_frame>at day 1</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Requiring Sedation in ICU</condition>
  <condition>Adult Patients</condition>
  <condition>Patient Covered by French Health Care System</condition>
  <arm_group>
    <arm_group_label>dexmedetomidine</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sedation with dexmedetomidine</intervention_name>
    <arm_group_label>dexmedetomidine</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients ventilated requiring sedation in ICU with RASS objective more than -2&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -Adult patients ventilated requiring sedation in ICU with RASS objective more than -2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  contraindication: intracranial lesion, hepatic failure&#xD;
&#xD;
          -  pregnancy&#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>Jean-Michel CONSTANTIN</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>November 2014</verification_date>
  <study_first_submitted>June 30, 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>November 25, 2014</last_update_submitted>
  <last_update_submitted_qc>November 25, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 26, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Sedation</keyword>
  <keyword>Dexmedetomidine</keyword>
  <keyword>ICU</keyword>
  <keyword>Delirium</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexmedetomidine</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/NCT02200159
org study id: CHU-0197
secondary id: 2013-000960-26
nct id: NCT02200159
lead sponsor: 
Research predictive factors of success or failure of a sedation with Dexmedetomidine in ICU
Prospective clinical study in ICU with sedated ventilated patients with dexmedetomidine,
      establishing incidence of success, failure of moderate sedation or failure of
      dexmedetomidine, to evaluate the effectiveness of this drug sedation in moderate sedation
observational model: Cohort
measure: Number of patients with failure of sedation with dexmedetomidine
time frame: at day 1
description: Number of patients with failure of sedation with dexmedetomidine (necessity to stop this sedation due to adverse event, RASS>+1, other) in ICU patients requiring such sedation during ICU stay.
measure: Incidence of adverse event of dexmedetomidine
time frame: at day 1
measure: Incidence of delirium and use of other sedative drugs
time frame: at day 1
arm group label: dexmedetomidine
intervention type: Drug
intervention name: Sedation with dexmedetomidine
arm group label: dexmedetomidine
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jean-Michel CONSTANTIN
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: Dexmedetomidine