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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01333319
First Posted: April 11, 2011
Last Update Posted: February 11, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
  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 ]

Secondary Outcome Measures:
  • Creatinine change [ Time Frame: First 5 days post transplantation ]

Biospecimen Retention:   Samples Without DNA
Whole blood, urine

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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


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

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01333319     History of Changes
Other Study ID Numbers: KILT1
First Submitted: April 8, 2011
First Posted: April 11, 2011
Last Update Posted: February 11, 2016
Last Verified: December 2015

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

Additional relevant MeSH terms:
Wounds and Injuries
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases