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

Renal Insufficiency, Acute Clinical Trial

Official title:

Early Biomarkers of Acute Kidney Injury in Liver Transplant Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00855127
• Other study ID #: 08-0769
• Status: Withdrawn
• Phase: N/A
• First received: March 3, 2009
• Last updated: May 28, 2015
• Start date: January 2009
• Est. completion date: July 2013

Study information

• Verified date: May 2015
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Kidney Injury
• Renal Insufficiency
• Renal Insufficiency, Acute

Locations

Country	Name	City	State
United States	University of Colorado Denver	Aurora	Colorado
United States	University of Washington	Seattle	Washington

Sponsors (4)

Lead Sponsor	Collaborator
University of Colorado, Denver	Children's Hospital Medical Center, Cincinnati, Denver Health Medical Center, University of Washington

Country where clinical trial is conducted

United States, 

References & 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. Review. — View Citation

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. Epub 2005 Sep 7. — View Citation

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. Epub 2006 May 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	The need for renal replacement therapy		After liver transplant operation to discharge	No
Secondary	All cause mortality		After liver transplant operation to discharge	No