Impact of Dexmedetomidine on Acute Kidney Injury Following Living Donor Liver Transplantation

Acute Kidney Injury Clinical Trial

Official title:

Impact of Dexmedetomidine on Acute Kidney Injury Following Living Donor Liver Transplantation: A Randomized Controlled Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03522688
• Other study ID #: DEX-LT
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: July 11, 2017
• Est. completion date: July 7, 2024

Study information

• Verified date: July 2023
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 214
• Est. completion date: July 7, 2024
• Est. primary completion date: July 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• living liver transplantation recipients

Exclusion Criteria:

• preoperative renal dysfunction
• dual living donor liver transplantation
• severe cerebral artery disease
• severe cardio-pulmonary disease

Related Conditions & MeSH terms

• Acute Kidney Injury
• Liver Diseases
• Wounds and Injuries

Intervention

Drug:
• Dexmedetomidine
The treatment group was given dexmedetomidine by constant intravenous (IV) infusion at a rate of 0.4mcg/kg/hour.
• Normal saline
The control group was given normal saline by constant intravenous (IV) infusion at a rate of 0.4mcg/kg/hour

Locations

Country	Name	City	State
Korea, Republic of	Asan medical center	Seoul	Songpa-gu

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	acute kidney injury	serum creatinine levels in postoperative 7 days	7 days
Secondary	lactate level	serial lactate level during operation and postoperative 3 days	3 days
Secondary	delirium	The incidence of delirium	postoperative day 7
Secondary	early allograft dysfunction	early allograft dysfunction	postoperative day 7
Secondary	duration of mechanical ventilation	duration of mechanical ventilation (hours)	up to 1 year
Secondary	intensive care unit length of stay	intensive care unit length of stay (days)	up to 1 year
Secondary	hospital length of stay	hospital length of stay (days)	up to 1 year
Secondary	graft failure	recipient death or re-transplantation within 1 year	1 year