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Clinical Trials/NCT01333319
NCT01333319
Completed
Not Applicable

The Role of Biomarkers in the Early Detection of Acute Kidney Injury Induced by Liver Transplantation : an Observational Analysis.

Universitaire Ziekenhuizen KU Leuven1 site in 1 country80 target enrollmentDecember 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Kidney Injury
Sponsor
Universitaire Ziekenhuizen KU Leuven
Enrollment
80
Locations
1
Primary Endpoint
Biomarkers in urine and plasma
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2011
End Date
December 1, 2015
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Older than 18 years

Exclusion Criteria

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

Outcomes

Primary Outcomes

Biomarkers in urine and plasma

Time Frame: First 5 days post transplantation

Secondary Outcomes

  • Creatinine change(First 5 days post transplantation)

Study Sites (1)

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