The Role of Biomarkers in the Early Detection of Acute Kidney Injury Induced by Liver Transplantation (KILT)
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.
Acute Kidney Injury
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||The Role of Biomarkers in the Early Detection of Acute Kidney Injury Induced by Liver Transplantation : an Observational Analysis.|
- Biomarkers in urine and plasma [ Time Frame: First 5 days post transplantation ] [ Designated as safety issue: No ]
- Creatinine change [ Time Frame: First 5 days post transplantation ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Whole blood, urine
|Study Start Date:||December 2011|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01333319
|University Hospitals Leuven|
|Principal Investigator:||Jacques Pirenne, MD, PhD||Abdominal Transplant Surgery, University Hospitals Leuven, KULeuven|