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

May 28, 2015 updated by: University of Colorado, Denver

Early Biomarkers of Acute Kidney Injury in Liver Transplant Patients

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.

Study Overview

Status

Withdrawn

Conditions

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.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Denver
    • Washington
      • Seattle, Washington, United States, 98105
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Liver transplant recipients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Within 2 to 5 days of liver transplant that is sustained for at least 24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Within 2-5 days of transplant that is sustained for at least 24 hours
The need for renal replacement therapy
Time Frame: After liver transplant operation to discharge
After liver transplant operation to discharge
All cause mortality
Time Frame: After liver transplant operation to discharge
After liver transplant operation to discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

University of Washington
Children's Hospital Medical Center, Cincinnati
Denver Health Medical Center

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

March 3, 2009

First Submitted That Met QC Criteria

March 3, 2009

First Posted (Estimate)

March 4, 2009

Study Record Updates

Last Update Posted (Estimate)

June 1, 2015

Last Update Submitted That Met QC Criteria

May 28, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-0769

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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