The Role of Biomarkers in the Early Detection of Acute Kidney Injury Induced by Liver Transplantation (KILT)
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|ClinicalTrials.gov Identifier: NCT01333319|
Recruitment Status : Unknown
Verified December 2015 by Universitaire Ziekenhuizen Leuven.
Recruitment status was: Active, not recruiting
First Posted : April 11, 2011
Last Update Posted : February 11, 2016
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.
|Condition or disease|
|Acute Kidney Injury|
|Study Type :||Observational|
|Estimated Enrollment :||80 participants|
|Official Title:||The Role of Biomarkers in the Early Detection of Acute Kidney Injury Induced by Liver Transplantation : an Observational Analysis.|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||June 2015|
- Biomarkers in urine and plasma [ Time Frame: First 5 days post transplantation ]
- Creatinine change [ Time Frame: First 5 days post transplantation ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01333319
|University Hospitals Leuven|
|Principal Investigator:||Jacques Pirenne, MD, PhD||Abdominal Transplant Surgery, University Hospitals Leuven, KULeuven|