<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/NCT02211053</url>
  </required_header>
  <id_info>
    <org_study_id>2014-987</org_study_id>
    <nct_id>NCT02211053</nct_id>
  </id_info>
  <brief_title>Evaluation of the Efficacy and Safety of Levothyroxine in Brain Death Organ Donors: a Randomized Controled Trial</brief_title>
  <acronym>ECHOT4</acronym>
  <official_title>Evaluation of the Efficacy and Safety of Levothyroxine in Brain Death Organ Donors: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hopital du Sacre-Coeur de Montreal</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hopital du Sacre-Coeur de Montreal</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to evaluate the feasibility of a randomized controlled&#xD;
      trial comparing levothyroxine to placebo in neurologically deceased donors&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Recruitment was too slow and we cannot anticipate to recruit the target sample size&#xD;
  </why_stopped>
  <start_date type="Actual">July 2014</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <phase>Phase 4</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>Supportive Care</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Study feasibility</measure>
    <time_frame>In 2 years</time_frame>
    <description>1) proportion of eligible recruited patients 2)proportion of recruited patients who completed the study 3) proportion of protocol violation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Variation in left ventricular ejection fraction</measure>
    <time_frame>6 hours post infusion</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Numbers of donated hearts</measure>
    <time_frame>On organ donation surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of de novo atrial fibrillation</measure>
    <time_frame>From beginning of infusion until beginning of retrieval surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time from recruitment to the administration of the study drug</measure>
    <time_frame>From randomization to 12 hours post randomization</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Brain Dead Organ Donors</condition>
  <arm_group>
    <arm_group_label>Levothyroxine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Levothyroxine infusion 20 mg IV bolus then 10 mg/h infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Infusion matched to intervention arm</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Levothyroxine</intervention_name>
    <description>20 mg IV bolus + 10 mg/h infusion</description>
    <arm_group_label>Levothyroxine</arm_group_label>
    <other_name>Synthroid(R)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Prior signed written informed from family member (no more needed following amendment&#xD;
             in July 2016)&#xD;
&#xD;
          -  16 years of age or older&#xD;
&#xD;
          -  Brain death diagnosis&#xD;
&#xD;
          -  Left ventricular ejection fraction &lt; 50% determined by transthoracic echocardiography&#xD;
             or hemodynamic instability defined as a mean dose of noradrenaline 0.1 mcg/kg/min +&#xD;
             vasopressin&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Heart failure history (removed after june 2015)&#xD;
&#xD;
          -  Chronic exogenous oral T4 or T3 before death (removed after june 2015)&#xD;
&#xD;
          -  Having received T4 infusion before recruitment(removed after june 2015)&#xD;
&#xD;
          -  Echographic images not interpretable&#xD;
&#xD;
               -  Age 75 and older(removed after june 2015)&#xD;
&#xD;
               -  Prior coronary heart disease defined as prior coronary artery bypass graft or&#xD;
                  percutaneous coronary intervention (with or without stents)(removed after june&#xD;
                  2015)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anne Julie Frenette, M.Sc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hopital du Sacre-Coeur de Montreal</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hopital du Sacré-Coeur de Montreal</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H4J1C5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>August 1, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <last_update_submitted>July 13, 2018</last_update_submitted>
  <last_update_submitted_qc>July 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hopital du Sacre-Coeur de Montreal</investigator_affiliation>
    <investigator_full_name>Anne Julie Frenette</investigator_full_name>
    <investigator_title>Intensive Care Pharmacist, Associate Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>Organ donation</keyword>
  <keyword>Brain dead</keyword>
  <keyword>Levothyroxine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Death</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/NCT02211053
org study id: 2014-987
nct id: NCT02211053
lead sponsor: 
has dmc: No
The primary objective of this study is to evaluate the feasibility of a randomized controlled
      trial comparing levothyroxine to placebo in neurologically deceased donors
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Study feasibility
time frame: In 2 years
description: 1) proportion of eligible recruited patients 2)proportion of recruited patients who completed the study 3) proportion of protocol violation
measure: Variation in left ventricular ejection fraction
time frame: 6 hours post infusion
measure: Numbers of donated hearts
time frame: On organ donation surgery
measure: Incidence of de novo atrial fibrillation
time frame: From beginning of infusion until beginning of retrieval surgery
measure: Time from recruitment to the administration of the study drug
time frame: From randomization to 12 hours post randomization
arm group label: Levothyroxine
arm group type: Active Comparator
description: Levothyroxine infusion 20 mg IV bolus then 10 mg/h infusion
arm group label: Placebo
arm group type: Placebo Comparator
description: Infusion matched to intervention arm
intervention type: Drug
intervention name: Levothyroxine
description: 20 mg IV bolus + 10 mg/h infusion
arm group label: Levothyroxine
other name: Synthroid(R)
intervention type: Drug
intervention name: placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Anne Julie Frenette, M.Sc
role: Principal Investigator
affiliation: Hopital du Sacre-Coeur de Montreal
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Hopital du Sacre-Coeur de Montreal
investigator full name: Anne Julie Frenette
investigator title: Intensive Care Pharmacist, Associate Clinical Professor
mesh term: Brain Death