Incidence, Risk Factors, and Risk Model of Acute Kidney Injury After Liver Transplantation

August 27, 2015 updated by: WonHo Kim, Samsung Medical Center
The incidence of acute kidney injury after liver transplantation has been reported to be 17 to 95 percent, but no definite treatment has been reported yet. Therefore, it is important to identify and prevent reversible risk factors for acute kidney injury after liver transplantation. Previous studies have reported several preoperative clinical risk factors, but preoperative medication and intraoperative colloid administration and hemodynamic parameters have not been evaluated. Therefore, we attempt to evaluate perioperative risk factors and develop simplified clinical risk scoring model.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Ischemia/reperfusion injury occurs during graft harvesting, cold storage, and surgical procedures in liver transplantation. Ischemia/reperfusion injury in liver graft results in major organ damage including kidney, lung and heart as well as graft dysfunction. Graft dysfunction and renal injury after liver transplantation are major clinical issues and are associated with prognosis and low survival rate. The incidence of acute kidney injury after liver transplantation has been reported to be 17 to 95 percent, but no definite treatment has been reported yet. Therefore, it is important to identify and prevent reversible risk factors for acute kidney injury after liver transplantation. Previous studies have reported several preoperative clinical risk factors, but perioperative medication, metabolic variables (albumin, glucose, uric acid), intraoperative colloid administration and hemodynamic parameters have not been evaluated. In addition, a neutrophil-lymphocyte ratio (NLR), which has been reported to be related to systemic inflammation and associated with prognosis of cardiac and cancer patients, might be related to the development of AKI after LDLT. Therefore, we attempt to evaluate these perioperative risk factors and develop simplified clinical risk scoring model.

Study Type

Observational

Enrollment (Actual)

573

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

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

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients who underwent living donor liver transplantation between 2010 and 2013

Description

Inclusion Criteria:

  • Patients who underwent living donor liver transplantation between 2010 and 2013 in Samsung Medical Center

Exclusion Criteria:

  • Incomplete data regarding pre- and postoperative creatinine and estimated Glomerular Filtration Rate
  • patient who underwent retransplantation

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
liver transplantation
patients who underwent living donor liver transplantation during between 2007 and 2013
Procedure: living donor liver transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
acute kidney injury as defined by RIFLE criteria
Time Frame: during 7 days after transplantation
acute kidney injury as defined by RIFLE criteria
during 7 days after transplantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of renal replacement therapy
Time Frame: during one month after transplantation
renal replacement therapy
during one month after transplantation
incidence of acute rejection of graft
Time Frame: during one month after transplantation
incidence of acute rejection of graft
during one month after transplantation
incidence of initial poor graft function
Time Frame: during one month after transplantation
incidence of initial poor graft function
during one month after transplantation
incidence of retransplantation
Time Frame: during one month after transplantation
incidence of retransplantation
during one month after transplantation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: during one month, six month, one year
Mortality during one month, six month, one year
during one month, six month, one year

Collaborators and Investigators

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

Sponsor

Samsung Medical Center

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

January 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

March 4, 2014

First Submitted That Met QC Criteria

March 5, 2014

First Posted (Estimate)

March 6, 2014

Study Record Updates

Last Update Posted (Estimate)

August 28, 2015

Last Update Submitted That Met QC Criteria

August 27, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-12-080

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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