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

NCT ID: NCT03522688

Last Updated: 2023-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

214 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-11

Study Completion Date

2024-07-07

Brief Summary

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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

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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.

Conditions

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Acute Kidney Injury Liver Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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control group

The control group was given normal saline by constant intravenous (IV) infusion at a rate of 0.4mcg/kg/hour

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

The control group was given normal saline by constant intravenous (IV) infusion at a rate of 0.4mcg/kg/hour

treatment group

The treatment group was given dexmedetomidine by constant intravenous (IV) infusion at a rate of 0.4mcg/kg/hour

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

The treatment group was given dexmedetomidine by constant intravenous (IV) infusion at a rate of 0.4mcg/kg/hour.

Interventions

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Dexmedetomidine

The treatment group was given dexmedetomidine by constant intravenous (IV) infusion at a rate of 0.4mcg/kg/hour.

Intervention Type DRUG

Normal saline

The control group was given normal saline by constant intravenous (IV) infusion at a rate of 0.4mcg/kg/hour

Intervention Type DRUG

Other Intervention Names

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precedex

Eligibility Criteria

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Inclusion Criteria

* living liver transplantation recipients

Exclusion Criteria

* preoperative renal dysfunction
* dual living donor liver transplantation
* severe cerebral artery disease
* severe cardio-pulmonary disease
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jun-Gol Song

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jun-Gol Song, PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Asan medical center

Seoul, Songpa-gu, South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 3556303 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26603801 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26444030 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29334927 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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DEX-LT

Identifier Type: -

Identifier Source: org_study_id

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