- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03522688
Impact of Dexmedetomidine on Acute Kidney Injury Following Living Donor Liver Transplantation
July 13, 2023 updated by: Jun-Gol Song, Asan Medical Center
Impact of Dexmedetomidine on Acute Kidney Injury Following Living Donor Liver Transplantation: A Randomized Controlled Study
Acute kidney injury (AKI) following liver transplantation (LT) is associated with increased costs, morbidity, and mortality.
Dexmedetomidine has known to have anti-inflammatory effect and has been shown to ameliorate IRI in several organs.
However, the impact of Dexmedetomidine on AKI after LT is not determined yet.
Therefore, this study aims to observe the renal protective effects of Dexmedetomidine after LT.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Acute kidney injury (AKI) following liver transplantation (LT) has shown a wide range of incidence between 17% and 95% and is associated with increased costs, morbidity, and mortality.
The etiology of AKI after LT is multifactorial.
Among these factors, renal ischemia-reperfusion injury (IRI) caused by perioperative renal hypoperfusion is considered as one of the most important independent risk factors and recent reports have indicated that IRI is associated with an inflammatory cascade.
Dexmedetomidine which is a highly selective agonist of α2-adrenergic receptors has known have anti-inflammatory effect and has been shown to ameliorate IRI in several organs.
However, the impact of Dexmedetomidine on AKI after LT is not determined yet.
Therefore, this study aims to observe the renal protective effects of Dexmedetomidine after LT.
Study Type
Interventional
Enrollment (Actual)
214
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jun-Gol Song, PhD
- Phone Number: +82-2-3010-3869
- Email: jungol.song@amc.seoul.kr
Study Locations
-
-
Songpa-gu
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Seoul, Songpa-gu, Korea, Republic of, 05505
- Asan Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- living liver transplantation recipients
Exclusion Criteria:
- preoperative renal dysfunction
- dual living donor liver transplantation
- severe cerebral artery disease
- severe cardio-pulmonary disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: treatment group
The treatment group was given dexmedetomidine by constant intravenous (IV) infusion at a rate of 0.4mcg/kg/hour
|
The treatment group was given dexmedetomidine by constant intravenous (IV) infusion at a rate of 0.4mcg/kg/hour.
Other Names:
|
Placebo Comparator: control group
The control group was given normal saline by constant intravenous (IV) infusion at a rate of 0.4mcg/kg/hour
|
The control group was given normal saline by constant intravenous (IV) infusion at a rate of 0.4mcg/kg/hour
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
acute kidney injury
Time Frame: 7 days
|
serum creatinine levels in postoperative 7 days
|
7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
lactate level
Time Frame: 3 days
|
serial lactate level during operation and postoperative 3 days
|
3 days
|
delirium
Time Frame: postoperative day 7
|
The incidence of delirium
|
postoperative day 7
|
early allograft dysfunction
Time Frame: postoperative day 7
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early allograft dysfunction
|
postoperative day 7
|
duration of mechanical ventilation
Time Frame: up to 1 year
|
duration of mechanical ventilation (hours)
|
up to 1 year
|
intensive care unit length of stay
Time Frame: up to 1 year
|
intensive care unit length of stay (days)
|
up to 1 year
|
hospital length of stay
Time Frame: up to 1 year
|
hospital length of stay (days)
|
up to 1 year
|
graft failure
Time Frame: 1 year
|
recipient death or re-transplantation within 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jun-Gol Song, PhD, Asan Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Rimola A, Gavaler JS, Schade RR, el-Lankany S, Starzl TE, Van Thiel DH. Effects of renal impairment on liver transplantation. Gastroenterology. 1987 Jul;93(1):148-56. doi: 10.1016/0016-5085(87)90327-1.
- Wyssusek KH, Keys AL, Yung J, Moloney ET, Sivalingam P, Paul SK. Evaluation of perioperative predictors of acute kidney injury post orthotopic liver transplantation. Anaesth Intensive Care. 2015 Nov;43(6):757-63. doi: 10.1177/0310057X1504300614.
- Cho JS, Shim JK, Soh S, Kim MK, Kwak YL. Perioperative dexmedetomidine reduces the incidence and severity of acute kidney injury following valvular heart surgery. Kidney Int. 2016 Mar;89(3):693-700. doi: 10.1038/ki.2015.306.
- Liu Y, Sheng B, Wang S, Lu F, Zhen J, Chen W. Dexmedetomidine prevents acute kidney injury after adult cardiac surgery: a meta-analysis of randomized controlled trials. BMC Anesthesiol. 2018 Jan 15;18(1):7. doi: 10.1186/s12871-018-0472-1.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 11, 2017
Primary Completion (Actual)
July 14, 2023
Study Completion (Estimated)
July 7, 2024
Study Registration Dates
First Submitted
May 1, 2018
First Submitted That Met QC Criteria
May 1, 2018
First Posted (Actual)
May 11, 2018
Study Record Updates
Last Update Posted (Actual)
July 17, 2023
Last Update Submitted That Met QC Criteria
July 13, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Kidney Diseases
- Urologic Diseases
- Renal Insufficiency
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Liver Diseases
- Wounds and Injuries
- Acute Kidney Injury
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Hypnotics and Sedatives
- Dexmedetomidine
Other Study ID Numbers
- DEX-LT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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