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

Sponsor
Asan Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT03522688
Collaborator
Kyongbo Pharmaceutical (Other)
134
1
2
19
7.1

Study Details

Study Description

Brief Summary

Acute kidney injury (AKI) following liver transplantation (LT) is associated with increased costs, morbidity, and mortality. Dexmedetomidine 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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

Acute kidney injury (AKI) following liver transplantation (LT) has shown a wide range of 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 Design

Study Type:
Interventional
Anticipated Enrollment :
134 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Prevention
Official Title:
Impact of Dexmedetomidine on Acute Kidney Injury Following Living Donor Liver Transplantation: A Randomized Controlled Study
Actual Study Start Date :
Jun 1, 2018
Anticipated Primary Completion Date :
Dec 31, 2019
Anticipated Study Completion Date :
Dec 31, 2019

Arms and Interventions

Arm Intervention/Treatment
No Intervention: control group

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

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
  • Outcome Measures

    Primary Outcome Measures

    1. acute kidney injury [7 days]

      serum creatinine levels in postoperative 7 days

    Secondary Outcome Measures

    1. early graft dysfunction [7 days]

      laboratory data in postoperative 7 days

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • living liver transplantation recipients
    Exclusion Criteria:
    • preoperative renal dysfunction

    • dual living donor liver transplantation

    • severe cerebral artery disease

    • severe cardio-pulmonary disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Asan medical center Seoul Songpa-gu Korea, Republic of 05505

    Sponsors and Collaborators

    • Asan Medical Center
    • Kyongbo Pharmaceutical

    Investigators

    • Principal Investigator: Jun-Gol Song, PhD, Asan Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Jun-Gol Song, Professor, Asan Medical Center
    ClinicalTrials.gov Identifier:
    NCT03522688
    Other Study ID Numbers:
    • DEX-LT
    First Posted:
    May 11, 2018
    Last Update Posted:
    Jul 29, 2019
    Last Verified:
    Jul 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jun-Gol Song, Professor, Asan Medical Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 29, 2019