Efficacy of Low-dose Dexmedetomidine to Prevent Delirium in Liver Transplant Patients
NCT02245256
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Adult patients (18years old or older) undergoing living-donor or deceased-donor liver transplantation
- Pediatric patients (under 18 years) Pregnancy Patients who are unresponsive at
baseline, who have neurologic deficits at baseline, or who are allergic to
dexmedetomidine
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Seoul, Agree
- San Francisco, California
- Tampa, Florida
- New Orleans, Louisiana
- Detroit, Michigan
- Rochester, Minnesota
- Omaha, Nebraska
- New York, New York
- Rochester, New York
- Cleveland, Ohio
- Philadelphia, Pennsylvania
- Gent,
- Edmonton, Alberta
- London, Ontario
- Toronto, Ontario
- Prague,
- Clichy,
- Lyon,
- Nice,
- Paris,
- Rennes,
- Villejuif,
- Berlin,
- Hamburg,
- München,
- Bologna,
- Milano,
- Padova,
- Leiden,
- Coimbra,
- Lisboa,
- Barcelona,
- Barcelona,
- Barcelona,
- Madrid,
- Pamplona,
- Santiago de Compostela,
- Valencia,
- Bern,
- Zürich,
- Birmingham,
- Edinburgh,
- Leeds,
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 |
| |||
Study Arms ICMJE |
| |||
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 | 217 | |||
Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
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 |
| |||
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 |