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Protective Effects of Dexmedetomidine on Myocardial Injury During Liver Transplantation

Primary Purpose

Evidence of Liver Transplantation, Myocardial Injury

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Dexmedetomidine
Normal saline
Sponsored by
Tianjin First Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Evidence of Liver Transplantation focused on measuring dexmedetomidine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • No.24 Fukang Road,Nankai DistrictRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dexmedetomidine Group

Normal saline Group

Arm Description

Dexmedetomidine infusion:loading 0.5ug/kg for 10min, then 0.5 ug/kg/h until the end of operation.

Equal volume normal saline substitute for dexmedetomidine

Outcomes

Primary Outcome Measures

Peri-operative mortality
The incidence of cardiac complications

Secondary Outcome Measures

Evidences of Clinically Definite Myocardial Injury Confirmed by Electrochemiluminescence
myohemoglobin,creatine kinase isoenzyme,cardiac troponinⅠ,Heart-type fatty acid-binding protein

Full Information

First Posted
December 22, 2016
Last Updated
January 4, 2017
Sponsor
Tianjin First Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03013634
Brief Title
Protective Effects of Dexmedetomidine on Myocardial Injury During Liver Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
November 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tianjin First Central Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study was to evaluate the protective effect of dexmedetomidine on myocardial injury during liver transplantation
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Evidence of Liver Transplantation, Myocardial Injury
Keywords
dexmedetomidine

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomidine Group
Arm Type
Experimental
Arm Description
Dexmedetomidine infusion:loading 0.5ug/kg for 10min, then 0.5 ug/kg/h until the end of operation.
Arm Title
Normal saline Group
Arm Type
Placebo Comparator
Arm Description
Equal volume normal saline substitute for dexmedetomidine
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
Dexmedetomidine infusion:loading 0.5ug/kg for 10min, then 0.5 ug/kg/h until the end of operation.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Equal volume normal saline substitute for dexmedetomidine
Primary Outcome Measure Information:
Title
Peri-operative mortality
Time Frame
through study completion, an average of 5 weeks
Title
The incidence of cardiac complications
Time Frame
from anesthesia induction to 24 hours after operation
Secondary Outcome Measure Information:
Title
Evidences of Clinically Definite Myocardial Injury Confirmed by Electrochemiluminescence
Description
myohemoglobin,creatine kinase isoenzyme,cardiac troponinⅠ,Heart-type fatty acid-binding protein
Time Frame
before skin incision, 0.5 hour min after anhepatic, 2 hours of neohepatic stage,the end of surgery,24 hours after operation
Other Pre-specified Outcome Measures:
Title
Length of ICU stay
Time Frame
through study completion, an average of 5 days
Title
length of stay
Description
from date of admission to discharge time
Time Frame
through study completion, an average of 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wenli Yu, PhD
Phone
86-13920098326
Email
yzxyuwenli@163.com
Facility Information:
Facility Name
No.24 Fukang Road,Nankai District
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300192
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenli Yu, PhD
Phone
86-13920098326
Email
yzxyuwenli@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Protective Effects of Dexmedetomidine on Myocardial Injury During Liver Transplantation

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