Efficacy of Low-dose Dexmedetomidine to Prevent Delirium in Liver Transplant Patients

September 23, 2019 updated by: Ho Geol Ryu, Seoul National University Hospital

Perioperative Low-dose Dexmedetomidine Decreases Incidence of Delirium in Liver Transplant Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

217

Phase

  • Phase 4

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

  • Korea, Republic of
    • Agree
      • Seoul, Agree, Korea, Republic of, 110-744
        • Seoul National University Hospital

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 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients (18years old or older) undergoing living-donor or deceased-donor liver transplantation

Exclusion Criteria:

  • Pediatric patients (under 18 years) Pregnancy Patients who are unresponsive at baseline, who have neurologic deficits at baseline, or who are allergic to dexmedetomidine

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
Placebo Comparator: Normal saline
same infusion rate as experimental group (dexmedetomidine)
Drug: placebo control
placebo
Other Names:
  • 0.9% saline
Experimental: dexmedetomidine
0.1mcg/kg/hr of dexmedetomidine infusion started after induction of anesthesia for liver transplantation and continued until 48 hours after surgery.
Drug: Precedex
infusion of 0.1mcg/kg/hr of precedex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
after August 25, 2014
1 week or transfer to ward, whichever comes first.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
after August 26, 2014
1 week or transfer to ward, whichever comes first.

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Collaborators

Hospira, now a wholly owned subsidiary of Pfizer

Investigators

  • Principal Investigator: Hogeol Ryu, MD, PhD, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 (Actual)

September 1, 2014

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

September 15, 2014

First Submitted That Met QC Criteria

September 18, 2014

First Posted (Estimate)

September 19, 2014

Study Record Updates

Last Update Posted (Actual)

September 25, 2019

Last Update Submitted That Met QC Criteria

September 23, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1407-114-596

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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