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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Universitaire Ziekenhuizen Leuven.
Recruitment status was  Active, not recruiting
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven Identifier:
First received: April 8, 2011
Last updated: May 28, 2015
Last verified: April 2011

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 Type: Observational
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.

Resource links provided by NLM:

Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • Biomarkers in urine and plasma [ Time Frame: First 5 days post transplantation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Creatinine change [ Time Frame: First 5 days post transplantation ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA
Whole blood, urine

Estimated Enrollment: 80
Study Start Date: December 2011
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients of the University Hospitals Leuven listed on the Eurotransplant waiting list for liver transplantation and undergoing a liver transplantation

Inclusion Criteria:

  • Older than 18 years

Exclusion Criteria:

  • Younger than 18 years old
  • Combined organ transplants
  • Dialysis dependent prior to liver transplantation
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Please refer to this study by its identifier: NCT01333319

University Hospitals Leuven
Leuven, Belgium
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Principal Investigator: Jacques Pirenne, MD, PhD Abdominal Transplant Surgery, University Hospitals Leuven, KULeuven
  More Information

No publications provided

Responsible Party: Universitaire Ziekenhuizen Leuven Identifier: NCT01333319     History of Changes
Other Study ID Numbers: KILT1
Study First Received: April 8, 2011
Last Updated: May 28, 2015
Health Authority: Belgium: Ethics Committee
Belgium: Institutional Review Board

Keywords provided by Universitaire Ziekenhuizen Leuven:
liver transplantation
acute kidney injury

Additional relevant MeSH terms:
Acute Kidney Injury
Kidney Diseases
Renal Insufficiency
Urologic Diseases processed this record on November 27, 2015