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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2011 by Universitaire Ziekenhuizen Leuven
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01333319
First received: April 8, 2011
Last updated: February 19, 2014
Last verified: April 2011
  Purpose

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
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: December 2014 (Final data collection date for primary outcome measure)
  Eligibility

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

Criteria

Inclusion Criteria:

  • Older than 18 years

Exclusion Criteria:

  • Younger than 18 years old
  • Combined organ transplants
  • Dialysis dependent prior to liver transplantation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01333319

Contacts
Contact: Nicolas Meurisse, MD nicolas.meurisse@med.kuleuven.be

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

No publications provided

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01333319     History of Changes
Other Study ID Numbers: KILT1
Study First Received: April 8, 2011
Last Updated: February 19, 2014
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

ClinicalTrials.gov processed this record on November 20, 2014