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

NCT02245256 | Completed Phase 4

• 1 other identifier: 1407-114-596
• Study Type: interventional
• Target: 217
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Transplantation

Keywords

delirium; incidence; dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• analysis of the incidence of postoperative delirium in liver transplant patients in the ICU.

  after August 25, 2014

  1 week or transfer to ward, whichever comes first.

Secondary Outcomes (1)

• analysis of the duration of postoperative delirium, ICU length of stay in liver transplant patients in the ICU.

  1 week or transfer to ward, whichever comes first.

Study Arms (2)

Normal saline

PLACEBO COMPARATOR

same infusion rate as experimental group (dexmedetomidine)

Drug: placebo control

dexmedetomidine

EXPERIMENTAL

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

Drug: Precedex

Interventions

Precedex DRUG

infusion of 0.1mcg/kg/hr of precedex

dexmedetomidine

placebo control DRUG

placebo

Also known as: 0.9% saline

Normal saline

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Hospira, now a wholly owned subsidiary of Pfizer: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, Agree, 110-744, South Korea

Location

Related Links

• Related Info

MeSH Terms

Conditions

Delirium

Interventions

Dexmedetomidine; Saline Solution

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Hogeol Ryu, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• 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: assistant professor

Study Record Dates

• First Submitted: September 15, 2014
• First Posted: September 19, 2014
• Study Start: September 1, 2014
• Primary Completion: January 1, 2018
• Study Completion: February 1, 2018
• Last Updated: September 25, 2019

Record last verified: 2019-09

Locations

KR (1)