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

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NCT02245256

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Study Location
Seoul National University Hospital
Seoul, Agree, 110-744, Korea, Republic of
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Liver Transplantation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-100 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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

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Advanced Information
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 Completed
Actual Enrollment  ICMJE
 (submitted: September 23, 2019)		217
Original Estimated Enrollment  ICMJE
 (submitted: September 18, 2014)		210
Actual Study Completion Date  ICMJE February 1, 2018
Actual Primary Completion Date January 1, 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 information is only displayed when the study is recruiting subjects
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, PhDSeoul National University Hospital
PRS Account Seoul National University Hospital
Verification Date September 2019

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