<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/NCT02245256</url>
  </required_header>
  <id_info>
    <org_study_id>1407-114-596</org_study_id>
    <nct_id>NCT02245256</nct_id>
  </id_info>
  <brief_title>Efficacy of Low-dose Dexmedetomidine to Prevent Delirium in Liver Transplant Patients</brief_title>
  <official_title>Perioperative Low-dose Dexmedetomidine Decreases Incidence of Delirium in Liver Transplant Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospira, now a wholly owned subsidiary of Pfizer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To test the effect of low-dose dexmedetomidine for lowering the incidence of postoperative&#xD;
      delirium in liver transplant patients in the ICU.&#xD;
&#xD;
      Single center prospective randomized placebo controlled clinical trial 0.1mcg/kg/hr of&#xD;
      dexmedetomidine or equivalent amount of saline infusion started after induction of anesthesia&#xD;
      for liver transplantation and continued until 48 hours after surgery.&#xD;
&#xD;
      Outcomes will be assessed up to 1 week or transfer to ward, whichever comes first.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2014</start_date>
  <completion_date type="Actual">February 1, 2018</completion_date>
  <primary_completion_date type="Actual">January 1, 2018</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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>analysis of the incidence of postoperative delirium in liver transplant patients in the ICU.</measure>
    <time_frame>1 week or transfer to ward, whichever comes first.</time_frame>
    <description>after August 25, 2014</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>analysis of the duration of postoperative delirium, ICU length of stay in liver transplant patients in the ICU.</measure>
    <time_frame>1 week or transfer to ward, whichever comes first.</time_frame>
    <description>after August 26, 2014</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">217</enrollment>
  <condition>Liver Transplantation</condition>
  <arm_group>
    <arm_group_label>Normal saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>same infusion rate as experimental group (dexmedetomidine)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>dexmedetomidine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>0.1mcg/kg/hr of dexmedetomidine infusion started after induction of anesthesia for liver transplantation and continued until 48 hours after surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Precedex</intervention_name>
    <description>infusion of 0.1mcg/kg/hr of precedex</description>
    <arm_group_label>dexmedetomidine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo control</intervention_name>
    <description>placebo</description>
    <arm_group_label>Normal saline</arm_group_label>
    <other_name>0.9% saline</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients (18years old or older) undergoing living-donor or deceased-donor liver&#xD;
             transplantation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pediatric patients (under 18 years) Pregnancy Patients who are unresponsive at&#xD;
             baseline, who have neurologic deficits at baseline, or who are allergic to&#xD;
             dexmedetomidine&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hogeol Ryu, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <state>Agree</state>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <link>
    <url>http://www.icudelirium.org</url>
    <description>Related Info</description>
  </link>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>September 15, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>September 23, 2019</last_update_submitted>
  <last_update_submitted_qc>September 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Ho Geol Ryu</investigator_full_name>
    <investigator_title>assistant professor</investigator_title>
  </responsible_party>
  <keyword>delirium</keyword>
  <keyword>incidence</keyword>
  <keyword>dexmedetomidine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Delirium</mesh_term>
  </condition_browse>
  <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/NCT02245256
org study id: 1407-114-596
nct id: NCT02245256
lead sponsor: 
collaborator: 
has dmc: No
To test the effect of low-dose dexmedetomidine for lowering the incidence of postoperative
      delirium in liver transplant patients in the ICU.

      Single center prospective randomized placebo controlled clinical trial 0.1mcg/kg/hr of
      dexmedetomidine or equivalent amount of saline infusion started after induction of anesthesia
      for liver transplantation and continued until 48 hours after surgery.

      Outcomes will be assessed up to 1 week or transfer to ward, whichever comes first.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: analysis of the incidence of postoperative delirium in liver transplant patients in the ICU.
time frame: 1 week or transfer to ward, whichever comes first.
description: after August 25, 2014
measure: analysis of the duration of postoperative delirium, ICU length of stay in liver transplant patients in the ICU.
time frame: 1 week or transfer to ward, whichever comes first.
description: after August 26, 2014
arm group label: Normal saline
arm group type: Placebo Comparator
description: same infusion rate as experimental group (dexmedetomidine)
arm group label: dexmedetomidine
arm group type: Experimental
description: 0.1mcg/kg/hr of dexmedetomidine infusion started after induction of anesthesia for liver transplantation and continued until 48 hours after surgery.
intervention type: Drug
intervention name: Precedex
description: infusion of 0.1mcg/kg/hr of precedex
arm group label: dexmedetomidine
intervention type: Drug
intervention name: placebo control
description: placebo
arm group label: Normal saline
other name: 0.9% saline
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Hogeol Ryu, MD, PhD
role: Principal Investigator
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
url: http://www.icudelirium.org
description: Related Info
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Ho Geol Ryu
investigator title: assistant professor
mesh term: Delirium
mesh term: Dexmedetomidine