Clinical trial NCT03522688: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Acute Kidney Injury
Liver Diseases
Keywords: dexmedetomidine
acute kidney injury
liver transplantation
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2018-05-11
Enrollment: 214
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: acute kidney injury
timeFrame: 7 days
Secondary outcomes:
measure: lactate level
timeFrame: 3 days
measure: delirium
timeFrame: postoperative day 7
measure: early allograft dysfunction
timeFrame: postoperative day 7
measure: duration of mechanical ventilation
timeFrame: up to 1 year
measure: intensive care unit length of stay
timeFrame: up to 1 year
measure: hospital length of stay
timeFrame: up to 1 year
measure: graft failure
timeFrame: 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan medical center
state: Songpa-gu
Study officials:
affiliation: Asan Medical Center
name: Jun-Gol Song, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.