NCT03013634

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 6, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

January 6, 2017

Status Verified

January 1, 2017

Enrollment Period

1 year

First QC Date

December 22, 2016

Last Update Submit

January 4, 2017

Conditions

Keywords

dexmedetomidine

Outcome Measures

Primary Outcomes (2)

  • Peri-operative mortality

    through study completion, an average of 5 weeks

  • The incidence of cardiac complications

    from anesthesia induction to 24 hours after operation

Secondary Outcomes (1)

  • Evidences of Clinically Definite Myocardial Injury Confirmed by Electrochemiluminescence

    before skin incision, 0.5 hour min after anhepatic, 2 hours of neohepatic stage,the end of surgery,24 hours after operation

Other Outcomes (2)

  • Length of ICU stay

    through study completion, an average of 5 days

  • length of stay

    through study completion, an average of 6 weeks

Study Arms (2)

Dexmedetomidine Group

EXPERIMENTAL

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

Drug: Dexmedetomidine

Normal saline Group

PLACEBO COMPARATOR

Equal volume normal saline substitute for dexmedetomidine

Drug: Normal saline

Interventions

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

Dexmedetomidine Group

Equal volume normal saline substitute for dexmedetomidine

Normal saline Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

No.24 Fukang Road,Nankai District

Tianjin, Tianjin Municipality, 300192, China

RECRUITING

MeSH Terms

Interventions

DexmedetomidineSaline Solution

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Wenli Yu,PhD ,Department of Anesthesiology,Tianjin First Center Hospital

Study Record Dates

First Submitted

December 22, 2016

First Posted

January 6, 2017

Study Start

October 1, 2016

Primary Completion

October 1, 2017

Study Completion

November 1, 2017

Last Updated

January 6, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations