Back to resultsImpact of Dexmedetomidine on Acute Kidney Injury Following Living Donor Liver Transplantation
Primary Purpose
Acute Kidney Injury, Liver Diseases
Status
Active
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dexmedetomidine
Normal saline
Sponsored by
About this trial
This is an interventional prevention trial for Acute Kidney Injury focused on measuring dexmedetomidine, acute kidney injury, liver transplantation
Eligibility Criteria
Inclusion Criteria:
- living liver transplantation recipients
Exclusion Criteria:
- preoperative renal dysfunction
- dual living donor liver transplantation
- severe cerebral artery disease
- severe cardio-pulmonary disease
Sites / Locations
- Asan medical center
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
control group
treatment group
Arm Description
The control group was given normal saline 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
Outcomes
Primary Outcome Measures
acute kidney injury
serum creatinine levels in postoperative 7 days
Secondary Outcome Measures
lactate level
serial lactate level during operation and postoperative 3 days
delirium
The incidence of delirium
early allograft dysfunction
early allograft dysfunction
duration of mechanical ventilation
duration of mechanical ventilation (hours)
intensive care unit length of stay
intensive care unit length of stay (days)
hospital length of stay
hospital length of stay (days)
graft failure
recipient death or re-transplantation within 1 year
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03522688
Brief Title
Impact of Dexmedetomidine on Acute Kidney Injury Following Living Donor Liver Transplantation
Official Title
Impact of Dexmedetomidine on Acute Kidney Injury Following Living Donor Liver Transplantation: A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 11, 2017 (Actual)
Primary Completion Date
July 14, 2023 (Actual)
Study Completion Date
July 7, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury, Liver Diseases
Keywords
dexmedetomidine, acute kidney injury, liver transplantation
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
214 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
The control group was given normal saline by constant intravenous (IV) infusion at a rate of 0.4mcg/kg/hour
Arm Title
treatment group
Arm Type
Active Comparator
Arm Description
The treatment group was given dexmedetomidine by constant intravenous (IV) infusion at a rate of 0.4mcg/kg/hour
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
precedex
Intervention Description
The treatment group was given dexmedetomidine by constant intravenous (IV) infusion at a rate of 0.4mcg/kg/hour.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
The control group was given normal saline by constant intravenous (IV) infusion at a rate of 0.4mcg/kg/hour
Primary Outcome Measure Information:
Title
acute kidney injury
Description
serum creatinine levels in postoperative 7 days
Time Frame
7 days
Secondary Outcome Measure Information:
Title
lactate level
Description
serial lactate level during operation and postoperative 3 days
Time Frame
3 days
Title
delirium
Description
The incidence of delirium
Time Frame
postoperative day 7
Title
early allograft dysfunction
Description
early allograft dysfunction
Time Frame
postoperative day 7
Title
duration of mechanical ventilation
Description
duration of mechanical ventilation (hours)
Time Frame
up to 1 year
Title
intensive care unit length of stay
Description
intensive care unit length of stay (days)
Time Frame
up to 1 year
Title
hospital length of stay
Description
hospital length of stay (days)
Time Frame
up to 1 year
Title
graft failure
Description
recipient death or re-transplantation within 1 year
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
living liver transplantation recipients
Exclusion Criteria:
preoperative renal dysfunction
dual living donor liver transplantation
severe cerebral artery disease
severe cardio-pulmonary disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun-Gol Song, PhD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan medical center
City
Seoul
State/Province
Songpa-gu
ZIP/Postal Code
05505
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
3556303
Citation
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.
Results Reference
background
PubMed Identifier
26603801
Citation
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.
Results Reference
background
PubMed Identifier
26444030
Citation
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.
Results Reference
background
PubMed Identifier
29334927
Citation
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.
Results Reference
background
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Impact of Dexmedetomidine on Acute Kidney Injury Following Living Donor Liver Transplantation
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