The Role of Biomarkers in the Early Detection of Acute Kidney Injury Induced by Liver Transplantation

Completed

• Conditions: Acute Kidney Injury

• Registration Number: NCT01333319
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

Renal dysfunction is a major risk factor for poorer outcome after liver transplantation. Nevertheless, mechanisms of renal dysfunction in liver transplant recipients are not clearly understood. Calcineurin inhibitors are generally perceived as the most important cause; however the liver transplant procedure itself represents a major surgical / hemodynamic / inflammatory trauma that - on its own - can cause renal dysfunction. Creatinine and creatinine clearance are late markers of acute kidney injury and changes in these parameters occur only after substantial injury has already occurred. Even a stable creatinine does not exclude structural kidney damage.

A series of new markers of tissue injury have been identified and have the potential to identify acute kidney injury better and earlier than creatinine and creatinine clearance. The aim of this study is to determine whether and how liver transplantation affects these urinary and plasma biomarkers and to study whether the changes in these biomarkers may predict later changes in standard functional parameters (creatinine and creatinine clearance). For this purpose, the urinary and plasma biomarkers, together with creatinine, will be determined serially during the different phases of the liver transplant process and daily until day 5 after transplantation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-04-08
• Study First Submitted QC: 2011-04-08
• Study First Posted: 2011-04-11
• Study Start: 2011-12
• Primary Completion: 2015-06
• Study Completion: 2015-12-01
• Status Verified: 2022-05
• Last Update Submitted: 2023-01-26
• Last Update Posted: 2023-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Older than 18 years

Exclusion Criteria

• Younger than 18 years old
• Combined organ transplants
• Dialysis dependent prior to liver transplantation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Biomarkers in urine and plasma	First 5 days post transplantation

Secondary Outcome Measures

Name	Time	Method
Creatinine change	First 5 days post transplantation

Trial Locations

Locations (1)

University Hospitals Leuven; 🇧🇪 Leuven, Belgium