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

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ClinicalTrials.gov Identifier: NCT03522688
Recruitment Status : Recruiting
First Posted : May 11, 2018
Last Update Posted : July 29, 2019
Sponsor:
Collaborator:
Kyongbo Pharmaceutical
Information provided by (Responsible Party):
Jun-Gol Song, Asan Medical Center

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
Acute Kidney Injury Liver Diseases Drug: Dexmedetomidine 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


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 Name: precedex




Primary Outcome Measures :
  1. acute kidney injury [ Time Frame: 7 days ]
    serum creatinine levels in postoperative 7 days


Secondary Outcome Measures :
  1. early graft dysfunction [ Time Frame: 7 days ]
    laboratory data in postoperative 7 days



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • living liver transplantation recipients

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03522688


Contacts
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Contact: Jun-Gol Song, PhD +82-2-3010-3869 jungol.song@amc.seoul.kr

Locations
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Korea, Republic of
Asan medical center Recruiting
Seoul, Songpa-gu, Korea, Republic of, 05505
Contact: Jun-Gol Song, Ph.D.    (+82)-2-3010-3869    jungol.song@amc.seoul.kr   
Contact: Kyeo-Woon Jung, M.D.    (+82)-2-3010-0751    india@amc.seoul.kr   
Sponsors and Collaborators
Asan Medical Center
Kyongbo Pharmaceutical
Investigators
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Principal Investigator: Jun-Gol Song, PhD Asan Medical Center
Publications:
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Responsible Party: Jun-Gol Song, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT03522688    
Other Study ID Numbers: DEX-LT
First Posted: May 11, 2018    Key Record Dates
Last Update Posted: July 29, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jun-Gol Song, Asan Medical Center:
dexmedetomidine
acute kidney injury
liver transplantation
Additional relevant MeSH terms:
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Liver Diseases
Acute Kidney Injury
Wounds and Injuries
Digestive System Diseases
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action