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

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ClinicalTrials.gov Identifier: NCT02245256
Recruitment Status : Recruiting
First Posted : September 19, 2014
Last Update Posted : January 25, 2018
Sponsor:
Collaborator:
Hospira, now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Ho Geol Ryu, Seoul National University Hospital

Tracking Information
First Submitted Date  ICMJE September 15, 2014
First Posted Date  ICMJE September 19, 2014
Last Update Posted Date January 25, 2018
Actual Study Start Date  ICMJE September 2014
Actual Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02245256 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2014)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Low-dose Dexmedetomidine to Prevent Delirium in Liver Transplant Patients
Official Title  ICMJE Perioperative Low-dose Dexmedetomidine Decreases Incidence of Delirium in Liver Transplant Patients
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Liver Transplantation
Intervention  ICMJE
  • Drug: Precedex
    infusion of 0.1mcg/kg/hr of precedex
  • Drug: placebo control
    placebo
    Other Name: 0.9% saline
Study Arms  ICMJE
  • Placebo Comparator: Normal saline
    same infusion rate as experimental group (dexmedetomidine)
    Intervention: Drug: placebo control
  • Experimental: dexmedetomidine
    0.1mcg/kg/hr of dexmedetomidine infusion started after induction of anesthesia for liver transplantation and continued until 48 hours after surgery.
    Intervention: Drug: Precedex
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 18, 2014)
210
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2018
Actual Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hogeol Ryu, MD, PhD 02-2072-2469 hogeol@gmail.com
Contact: Hannah Lee, MD 02-2072-3538 closerthan@gmail.com
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02245256
Other Study ID Numbers  ICMJE 1407-114-596
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ho Geol Ryu, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Hospira, now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator: Hogeol Ryu, MD, PhD Seoul National University Hospital
PRS Account Seoul National University Hospital
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP