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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

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.


Condition or disease Intervention/treatment Phase
Liver Transplantation Drug: Precedex Drug: placebo control Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Perioperative Low-dose Dexmedetomidine Decreases Incidence of Delirium in Liver Transplant Patients
Actual Study Start Date : September 2014
Actual Primary Completion Date : January 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Normal saline
same infusion rate as experimental group (dexmedetomidine)
Drug: placebo control
placebo
Other Name: 0.9% saline

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02245256


Contacts
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Contact: Hogeol Ryu, MD, PhD 02-2072-2469 hogeol@gmail.com
Contact: Hannah Lee, MD 02-2072-3538 closerthan@gmail.com

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Agree, Korea, Republic of, 110-744
Contact: Hogeol Ryu, MD, PhD    82-2-2072-2469    hogeol@gmail.com   
Contact: Hannah Lee, MD    82-2-2072-3538    closerthan@gmail.com   
Principal Investigator: Hogeol Ryu, MD, PhD         
Sponsors and Collaborators
Seoul National University Hospital
Hospira, now a wholly owned subsidiary of Pfizer
Investigators
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Principal Investigator: Hogeol Ryu, MD, PhD Seoul National University Hospital

Additional Information:
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Responsible Party: Ho Geol Ryu, assistant professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02245256     History of Changes
Other Study ID Numbers: 1407-114-596
First Posted: September 19, 2014    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018

Keywords provided by Ho Geol Ryu, Seoul National University Hospital:
delirium
incidence
dexmedetomidine

Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action