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

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: Liver Diseases; Acute Kidney Injury
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Normal saline

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

• Study Contact: Name: Jun-Gol Song, PhD; Phone Number: +82-2-3010-3869; Email: jungol.song@amc.seoul.kr

Study Locations

• Korea, Republic of
  • Songpa-gu
    • Seoul, Songpa-gu, Korea, Republic of, 05505
      • Asan Medical Center

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

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	Drug: Dexmedetomidine; The treatment group was given dexmedetomidine by constant intravenous (IV) infusion at a rate of 0.4mcg/kg/hour.; Other Names: precedex
Placebo Comparator: control group; The control group was given normal saline by constant intravenous (IV) infusion at a rate of 0.4mcg/kg/hour	Drug: Normal saline; 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	serum creatinine levels in postoperative 7 days	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
lactate level	serial lactate level during operation and postoperative 3 days	3 days
delirium	The incidence of delirium	postoperative day 7
early allograft dysfunction	early allograft dysfunction	postoperative day 7
duration of mechanical ventilation	duration of mechanical ventilation (hours)	up to 1 year
intensive care unit length of stay	intensive care unit length of stay (days)	up to 1 year
hospital length of stay	hospital length of stay (days)	up to 1 year
graft failure	recipient death or re-transplantation within 1 year	1 year

Collaborators and Investigators

• Sponsor: Asan Medical Center
• Collaborators: Kyongbo Pharmaceutical
• Investigators: Principal Investigator: Jun-Gol Song, PhD, Asan Medical Center

Publications and helpful links

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

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

• Keywords: acute kidney injury; liver transplantation; dexmedetomidine
• 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