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

NCT ID: NCT02245256

Last Updated: 2019-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

217 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-01

Study Completion Date

2018-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Liver Transplantation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Normal saline

same infusion rate as experimental group (dexmedetomidine)

Group Type PLACEBO_COMPARATOR

placebo control

Intervention Type DRUG

placebo

dexmedetomidine

0.1mcg/kg/hr of dexmedetomidine infusion started after induction of anesthesia for liver transplantation and continued until 48 hours after surgery.

Group Type EXPERIMENTAL

Precedex

Intervention Type DRUG

infusion of 0.1mcg/kg/hr of precedex

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Precedex

infusion of 0.1mcg/kg/hr of precedex

Intervention Type DRUG

placebo control

placebo

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

0.9% saline

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospira, now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ho Geol Ryu

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hogeol Ryu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Seoul National University Hospital

Seoul, Agree, South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1407-114-596

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.