New Urine and Blood Markers for Acute Kidney Injury in Liver Transplant Patients

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
University of Washington
Denver Health Medical Center
Children's Hospital Medical Center, Cincinnati
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00855127
First received: March 3, 2009
Last updated: January 3, 2013
Last verified: March 2009
  Purpose

The purpose of this study is to find new blood and urine tests that detect acute kidney injury earlier than our current blood tests in patients receiving a liver transplant.


Condition
Renal Insufficiency, Acute

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Biomarkers of Acute Kidney Injury in Liver Transplant Patients

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Development of acute kidney injury as defined by a 50% increase in serum creatinine [ Time Frame: Within 2 to 5 days of liver transplant that is sustained for at least 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Development of severe acute kidney injury, as defined as a doubling of serum creatinine [ Time Frame: Within 2-5 days of transplant that is sustained for at least 24 hours ] [ Designated as safety issue: No ]
  • The need for renal replacement therapy [ Time Frame: After liver transplant operation to discharge ] [ Designated as safety issue: No ]
  • All cause mortality [ Time Frame: After liver transplant operation to discharge ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Urine supernatent Serum


Estimated Enrollment: 250
Study Start Date: January 2009
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Liver transplant recipients

Detailed Description:

Patients with end stage liver disease that receive a liver transplant will be studied to determine if novel serum and urine biomarkers (serum cystatin C, urine interleukin-18 [IL-18] and urine neutrophil gelatinase associated lipocalin [NGAL]) can predict the outcome measures listed above.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients presenting to the University of Colorado Hospital or the University of Washington Medical Center for a liver transplant operation

Criteria

Inclusion Criteria:

  • First time liver transplant recipient
  • Cadaveric or living donor livers

Exclusion Criteria:

  • Unconscious patients or patients who cannot give consent
  • Pregnant women
  • Prisoners
  • Patients receiving dialysis before or during liver transplant operation
  • Patients receiving simultaneous liver-kidney transplants
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00855127

Locations
United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
United States, Washington
University of Washington
Seattle, Washington, United States, 98105
Sponsors and Collaborators
University of Colorado, Denver
University of Washington
Denver Health Medical Center
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Angela M Walcher, MD University of Colorado, Denver
Study Director: Charles L Edelstein, MD, PhD University of Colorado, Denver
Study Director: Connie L Davis, MD University of Washington
  More Information

Publications:
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00855127     History of Changes
Other Study ID Numbers: 08-0769
Study First Received: March 3, 2009
Last Updated: January 3, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
Biological Markers
Renal Replacement Therapy
Mortality

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

ClinicalTrials.gov processed this record on April 15, 2014