Overview

This trial is active, not recruiting.

Condition acute kidney injury
Sponsor Universitaire Ziekenhuizen Leuven
Start date December 2011
End date June 2015
Trial size 80 participants
Trial identifier NCT01333319, KILT1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Biomarkers in urine and plasma
time frame: First 5 days post transplantation

Secondary Outcomes

Measure
Creatinine change
time frame: First 5 days post transplantation

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Older than 18 years Exclusion Criteria: - Younger than 18 years old - Combined organ transplants - Dialysis dependent prior to liver transplantation

Additional Information

Official title The Role of Biomarkers in the Early Detection of Acute Kidney Injury Induced by Liver Transplantation : an Observational Analysis.
Principal investigator Jacques Pirenne, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Universitaire Ziekenhuizen Leuven.