NCT03522688

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
214

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2017

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 11, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 11, 2018

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2023

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2024

Completed
Last Updated

July 17, 2023

Status Verified

July 1, 2023

Enrollment Period

6 years

First QC Date

May 1, 2018

Last Update Submit

July 13, 2023

Conditions

Acute Kidney InjuryLiver Diseases

Keywords

dexmedetomidineacute kidney injuryliver transplantation

Outcome Measures

Primary Outcomes (1)

  • acute kidney injury

    serum creatinine levels in postoperative 7 days

    7 days

Secondary Outcomes (7)

  • lactate level

    3 days

  • delirium

    postoperative day 7

  • early allograft dysfunction

    postoperative day 7

  • duration of mechanical ventilation

    up to 1 year

  • intensive care unit length of stay

    up to 1 year

  • +2 more secondary outcomes

Study Arms (2)

control group

PLACEBO COMPARATOR

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

Drug: Normal saline

treatment group

ACTIVE COMPARATOR

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

Drug: Dexmedetomidine

Interventions

DexmedetomidineDRUG

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

Also known as: precedex
treatment group
Normal salineDRUG

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

control group

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • living liver transplantation recipients

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan medical center

Seoul, Songpa-gu, 05505, South Korea

Location

Related Publications (4)

  • 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.

    PMID: 3556303BACKGROUND

  • 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.

    PMID: 26603801BACKGROUND

  • 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.

    PMID: 26444030BACKGROUND

  • 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.

    PMID: 29334927BACKGROUND

MeSH Terms

Conditions

Acute Kidney InjuryLiver Diseases

Interventions

DexmedetomidineSaline Solution

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Jun-Gol Song, PhD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 1, 2018

First Posted

May 11, 2018

Study Start

July 11, 2017

Primary Completion

July 14, 2023

Study Completion

July 7, 2024

Last Updated

July 17, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)