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

NCT ID: NCT00855127

Last Updated: 2015-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2013-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Renal Insufficiency, Acute

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Liver transplant recipients

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Washington

OTHER

Sponsor Role collaborator

Denver Health Medical Center

OTHER

Sponsor Role collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Angela M Walcher, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Charles L Edelstein, MD, PhD

Role: STUDY_DIRECTOR

University of Colorado, Denver

Connie L Davis, MD

Role: STUDY_DIRECTOR

University of Washington

Locations

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University of Colorado Denver

Aurora, Colorado, United States

Site Status

University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Edelstein CL. Biomarkers of acute kidney injury. Adv Chronic Kidney Dis. 2008 Jul;15(3):222-34. doi: 10.1053/j.ackd.2008.04.003.

Reference Type BACKGROUND
PMID: 18565474 (View on PubMed)

Parikh CR, Mishra J, Thiessen-Philbrook H, Dursun B, Ma Q, Kelly C, Dent C, Devarajan P, Edelstein CL. Urinary IL-18 is an early predictive biomarker of acute kidney injury after cardiac surgery. Kidney Int. 2006 Jul;70(1):199-203. doi: 10.1038/sj.ki.5001527. Epub 2006 May 17.

Reference Type BACKGROUND
PMID: 16710348 (View on PubMed)

Parikh CR, Abraham E, Ancukiewicz M, Edelstein CL. Urine IL-18 is an early diagnostic marker for acute kidney injury and predicts mortality in the intensive care unit. J Am Soc Nephrol. 2005 Oct;16(10):3046-52. doi: 10.1681/ASN.2005030236. Epub 2005 Sep 7.

Reference Type BACKGROUND
PMID: 16148039 (View on PubMed)

Other Identifiers

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08-0769

Identifier Type: -

Identifier Source: org_study_id

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