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

Primary Purpose

Liver Transplantation

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Precedex
placebo control
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Liver Transplantation focused on measuring delirium, incidence, dexmedetomidine

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Normal saline

dexmedetomidine

Arm Description

same infusion rate as experimental group (dexmedetomidine)

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

Outcomes

Primary Outcome Measures

analysis of the incidence of postoperative delirium in liver transplant patients in the ICU.
after August 25, 2014

Secondary Outcome Measures

analysis of the duration of postoperative delirium, ICU length of stay in liver transplant patients in the ICU.
after August 26, 2014

Full Information

First Posted
September 15, 2014
Last Updated
September 23, 2019
Sponsor
Seoul National University Hospital
Collaborators
Hospira, now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT02245256
Brief Title
Efficacy of Low-dose Dexmedetomidine to Prevent Delirium in Liver Transplant Patients
Official Title
Perioperative Low-dose Dexmedetomidine Decreases Incidence of Delirium in Liver Transplant Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2014 (Actual)
Primary Completion Date
January 1, 2018 (Actual)
Study Completion Date
February 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Hospira, now a wholly owned subsidiary of Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Transplantation
Keywords
delirium, incidence, dexmedetomidine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
217 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal saline
Arm Type
Placebo Comparator
Arm Description
same infusion rate as experimental group (dexmedetomidine)
Arm Title
dexmedetomidine
Arm Type
Experimental
Arm Description
0.1mcg/kg/hr of dexmedetomidine infusion started after induction of anesthesia for liver transplantation and continued until 48 hours after surgery.
Intervention Type
Drug
Intervention Name(s)
Precedex
Intervention Description
infusion of 0.1mcg/kg/hr of precedex
Intervention Type
Drug
Intervention Name(s)
placebo control
Other Intervention Name(s)
0.9% saline
Intervention Description
placebo
Primary Outcome Measure Information:
Title
analysis of the incidence of postoperative delirium in liver transplant patients in the ICU.
Description
after August 25, 2014
Time Frame
1 week or transfer to ward, whichever comes first.
Secondary Outcome Measure Information:
Title
analysis of the duration of postoperative delirium, ICU length of stay in liver transplant patients in the ICU.
Description
after August 26, 2014
Time Frame
1 week or transfer to ward, whichever comes first.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hogeol Ryu, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Agree
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

Links:
URL
http://www.icudelirium.org
Description
Related Info

Learn more about this trial

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

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