<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/NCT03013634</url>
  </required_header>
  <id_info>
    <org_study_id>TianjinFCH</org_study_id>
    <nct_id>NCT03013634</nct_id>
  </id_info>
  <brief_title>Protective Effects of Dexmedetomidine on Myocardial Injury During Liver Transplantation</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tianjin First Central Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tianjin First Central Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to evaluate the protective effect of dexmedetomidine on&#xD;
      myocardial injury during liver transplantation&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Liver transplantation surgery may lead to myocardial injury. Dexmedetomidine, a highly&#xD;
      specific α2-adrenoeptor agonist, has sedative and analgesic properties without significant&#xD;
      respiratory depression at the clinically approved dosage. Some investigations indicated that&#xD;
      dexmedetomidine was able to protect the myocardium via improving the activity of&#xD;
      Na+-K+-adenosine triphosphate enzyme and Ca2+-adenosine triphosphate, alleviating&#xD;
      inflammation reaction and avoiding Ca2+ overload. However, the effect and the mechanism of&#xD;
      dexmedetomidine on myocardial injury during liver transplantation remain unclear.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2016</start_date>
  <completion_date type="Anticipated">November 2017</completion_date>
  <primary_completion_date type="Anticipated">October 2017</primary_completion_date>
  <phase>N/A</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>Peri-operative mortality</measure>
    <time_frame>through study completion, an average of 5 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The incidence of cardiac complications</measure>
    <time_frame>from anesthesia induction to 24 hours after operation</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evidences of Clinically Definite Myocardial Injury Confirmed by Electrochemiluminescence</measure>
    <time_frame>before skin incision, 0.5 hour min after anhepatic, 2 hours of neohepatic stage,the end of surgery,24 hours after operation</time_frame>
    <description>myohemoglobin,creatine kinase isoenzyme,cardiac troponinⅠ,Heart-type fatty acid-binding protein</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Length of ICU stay</measure>
    <time_frame>through study completion, an average of 5 days</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>length of stay</measure>
    <time_frame>through study completion, an average of 6 weeks</time_frame>
    <description>from date of admission to discharge time</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Evidence of Liver Transplantation</condition>
  <condition>Myocardial Injury</condition>
  <arm_group>
    <arm_group_label>Dexmedetomidine Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dexmedetomidine infusion:loading 0.5ug/kg for 10min, then 0.5 ug/kg/h until the end of operation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal saline Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Equal volume normal saline substitute for dexmedetomidine</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine</intervention_name>
    <description>Dexmedetomidine infusion:loading 0.5ug/kg for 10min, then 0.5 ug/kg/h until the end of operation.</description>
    <arm_group_label>Dexmedetomidine Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal saline</intervention_name>
    <description>Equal volume normal saline substitute for dexmedetomidine</description>
    <arm_group_label>Normal saline Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  End stage liver disease scheduled for liver transplantation in Tianjin First Center&#xD;
             Hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pre-existing respiratory failure,renal failure,hepatic encephalopathy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Wenli Yu, PhD</last_name>
    <phone>86-13920098326</phone>
    <email>yzxyuwenli@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>No.24 Fukang Road,Nankai District</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300192</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wenli Yu, PhD</last_name>
      <phone>86-13920098326</phone>
      <email>yzxyuwenli@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 22, 2016</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>January 4, 2017</last_update_submitted>
  <last_update_submitted_qc>January 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tianjin First Central Hospital</investigator_affiliation>
    <investigator_full_name>Wenli Yu</investigator_full_name>
    <investigator_title>Wenli Yu,PhD ,Department of Anesthesiology,Tianjin First Center Hospital</investigator_title>
  </responsible_party>
  <keyword>dexmedetomidine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexmedetomidine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03013634
org study id: TianjinFCH
nct id: NCT03013634
lead sponsor: 
has dmc: Yes
The purpose of this study was to evaluate the protective effect of dexmedetomidine on
      myocardial injury during liver transplantation
Liver transplantation surgery may lead to myocardial injury. Dexmedetomidine, a highly
      specific α2-adrenoeptor agonist, has sedative and analgesic properties without significant
      respiratory depression at the clinically approved dosage. Some investigations indicated that
      dexmedetomidine was able to protect the myocardium via improving the activity of
      Na+-K+-adenosine triphosphate enzyme and Ca2+-adenosine triphosphate, alleviating
      inflammation reaction and avoiding Ca2+ overload. However, the effect and the mechanism of
      dexmedetomidine on myocardial injury during liver transplantation remain unclear.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Peri-operative mortality
time frame: through study completion, an average of 5 weeks
measure: The incidence of cardiac complications
time frame: from anesthesia induction to 24 hours after operation
measure: Evidences of Clinically Definite Myocardial Injury Confirmed by Electrochemiluminescence
time frame: before skin incision, 0.5 hour min after anhepatic, 2 hours of neohepatic stage,the end of surgery,24 hours after operation
description: myohemoglobin,creatine kinase isoenzyme,cardiac troponinⅠ,Heart-type fatty acid-binding protein
measure: Length of ICU stay
time frame: through study completion, an average of 5 days
measure: length of stay
time frame: through study completion, an average of 6 weeks
description: from date of admission to discharge time
arm group label: Dexmedetomidine Group
arm group type: Experimental
description: Dexmedetomidine infusion:loading 0.5ug/kg for 10min, then 0.5 ug/kg/h until the end of operation.
arm group label: Normal saline Group
arm group type: Placebo Comparator
description: Equal volume normal saline substitute for dexmedetomidine
intervention type: Drug
intervention name: Dexmedetomidine
description: Dexmedetomidine infusion:loading 0.5ug/kg for 10min, then 0.5 ug/kg/h until the end of operation.
arm group label: Dexmedetomidine Group
intervention type: Drug
intervention name: Normal saline
description: Equal volume normal saline substitute for dexmedetomidine
arm group label: Normal saline Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Wenli Yu, PhD
phone: 86-13920098326
email: yzxyuwenli@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Tianjin First Central Hospital
investigator full name: Wenli Yu
investigator title: Wenli Yu,PhD ,Department of Anesthesiology,Tianjin First Center Hospital
mesh term: Wounds and Injuries
mesh term: Dexmedetomidine
sharing ipd: No