Identification of Genetic Polymorphism Related to Acute Kidney Injury After Liver Transplantation Through Genome-wide Association Study (GWAS) in Korean Population

January 10, 2019 updated by: Yonsei University
Some of the liver transplantation recipients experience postoperative acute kidney injury due to various causes including genetic factors. Prevention of postoperative acute kidney injury is essential for postoperative care in liver transplantation recipients. The aim of this study is to investigate the relationship between gene polymorphisms and the occurrence of acute kidney injury after liver transplantation by performing genome-wide association study (GWAS).

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

330

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Recruiting
        • Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
        • Contact:
          • Seung Ho Choi, MD
          • Phone Number: +82-2-2228-2420
          • Email: csho99@yuhs.ac

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients scheduled for liver transplantation

Description

Inclusion Criteria:

1) adult patients scheduled for liver transplantation

Exclusion Criteria:

  1. Patients on dialysis
  2. patients not able to read, or understand the consent form
  3. ethnicity, other than asian
  4. patients refusal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Prospective cohort
Adult patients undergoing liver transplantation will be included and followed up during the first 72 hours post-liver transplantation in order to confirm the development of acute kidney injury. The patients will be divided into two groups (AKI group vs. non-AKI group) according to the development of acute kidney injury. The GWAS will be performed with the blood obtained from enrolled patients.
Retrospective cohort
In previous study performed in adult patients undergoing liver transplantation (NCT02489474, 4-2015-0411), we enrolled patients and collected data regarding the development of acute kidney injury during the first 72 hours post-liver transplantation. Among these patients enrolled in this previous study, only patients who agreed to additional use of the blood sample for research purposes will be included in the present study. The GWAS will be performed with the blood obtained from enrolled patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute kidney injury after liver transplantation
Time Frame: Participants will be followed up during the first 72 hours post-liver transplantation in order to confirm the development of acute kidney injury.
The development of acute kidney injury is defined by the following definition: 50% increase in SCr from the baseline (preoperative value) or a 0.3 mg/dl increase from baseline within 48 h without urine output. The development of acute kidney injury after liver transplantation could correlate with gene polymorphisms, which have been known to be associated with postoperative acute kidney injury.
Participants will be followed up during the first 72 hours post-liver transplantation in order to confirm the development of acute kidney injury.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2017

Primary Completion (Anticipated)

November 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

November 13, 2017

First Submitted That Met QC Criteria

November 13, 2017

First Posted (Actual)

November 17, 2017

Study Record Updates

Last Update Posted (Actual)

January 11, 2019

Last Update Submitted That Met QC Criteria

January 10, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2017-0888

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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