NCT02489474

Brief Summary

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 which have been known to be associated with postoperative acute kidney injury, and the occurrence of acute kidney injury after liver transplantation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
124

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 3, 2015

Completed
7 days until next milestone

Study Start

First participant enrolled

July 10, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2017

Completed
Last Updated

July 17, 2018

Status Verified

July 1, 2018

Enrollment Period

2.4 years

First QC Date

July 1, 2015

Last Update Submit

July 15, 2018

Conditions

Liver Transplantation

Outcome Measures

Primary Outcomes (1)

  • Acute kidney injury after liver transplantation

    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.

    72 hours

Study Arms (1)

Recipients undergoing liver transplantation

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.

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients scheduled for liver transplantation

You may qualify if:

  • \) adult patients scheduled for liver transplantation

You may not qualify if:

  • Patients on dialysis
  • patients not able to read, or understand the consent form
  • ethnicity, other than asian
  • patients refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine

Seoul, 120-752, South Korea

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood obtained from enrolled patients before surgery

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2015

First Posted

July 3, 2015

Study Start

July 10, 2015

Primary Completion

November 16, 2017

Study Completion

November 16, 2017

Last Updated

July 17, 2018

Record last verified: 2018-07

Locations

KR(1)