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

NCT00855127 | Withdrawn

• 1 other identifier: 08-0769
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Renal Insufficiency, Acute

Keywords

Biological Markers; Renal Replacement Therapy; Mortality

Outcome Measures

Primary Outcomes (1)

• Development of acute kidney injury as defined by a 50% increase in serum creatinine

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

Secondary Outcomes (3)

• Development of severe acute kidney injury, as defined as a doubling of serum creatinine

  Within 2-5 days of transplant that is sustained for at least 24 hours

• The need for renal replacement therapy

  After liver transplant operation to discharge

• All cause mortality

  After liver transplant operation to discharge

Study Arms (1)

Liver transplant recipients

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• University of Washington: collaborator
• Denver Health Medical Center: collaborator
• Children's Hospital Medical Center, Cincinnati: collaborator

Study Sites (2)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

University of Washington

Seattle, Washington, 98105, United States

Location

Related Publications (3)

• 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.

  PMID: 18565474 BACKGROUND

• 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.

  PMID: 16710348 BACKGROUND

• 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.

  PMID: 16148039 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine supernatent Serum

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Angela M Walcher, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

• Charles L Edelstein, MD, PhD

  University of Colorado, Denver

  STUDY DIRECTOR

• Connie L Davis, MD

  University of Washington

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2009
• First Posted: March 4, 2009
• Study Start: January 1, 2009
• Primary Completion: June 1, 2013
• Study Completion: July 1, 2013
• Last Updated: June 1, 2015

Record last verified: 2015-05

Locations

US (2)