Protective Effects of Dexmedetomidine on Myocardial Injury During Liver Transplantation

January 4, 2017 updated by: Wenli Yu, Tianjin First Central Hospital
The purpose of this study was to evaluate the protective effect of dexmedetomidine on myocardial injury during liver transplantation

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China, 300192
        • Recruiting
        • No.24 Fukang Road,Nankai District
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • End stage liver disease scheduled for liver transplantation in Tianjin First Center Hospital

Exclusion Criteria:

  • Pre-existing respiratory failure,renal failure,hepatic encephalopathy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dexmedetomidine Group
Dexmedetomidine infusion:loading 0.5ug/kg for 10min, then 0.5 ug/kg/h until the end of operation.
Drug: Dexmedetomidine
Dexmedetomidine infusion:loading 0.5ug/kg for 10min, then 0.5 ug/kg/h until the end of operation.
Placebo Comparator: Normal saline Group
Equal volume normal saline substitute for dexmedetomidine
Drug: Normal saline
Equal volume normal saline substitute for dexmedetomidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Peri-operative mortality
Time Frame: through study completion, an average of 5 weeks
through study completion, an average of 5 weeks
The incidence of cardiac complications
Time Frame: from anesthesia induction to 24 hours after operation
from anesthesia induction to 24 hours after operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
myohemoglobin,creatine kinase isoenzyme,cardiac troponinⅠ,Heart-type fatty acid-binding protein
before skin incision, 0.5 hour min after anhepatic, 2 hours of neohepatic stage,the end of surgery,24 hours after operation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of ICU stay
Time Frame: through study completion, an average of 5 days
through study completion, an average of 5 days
length of stay
Time Frame: through study completion, an average of 6 weeks
from date of admission to discharge time
through study completion, an average of 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin First Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

November 1, 2017

Study Registration Dates

First Submitted

December 22, 2016

First Submitted That Met QC Criteria

January 4, 2017

First Posted (Estimate)

January 6, 2017

Study Record Updates

Last Update Posted (Estimate)

January 6, 2017

Last Update Submitted That Met QC Criteria

January 4, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TianjinFCH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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