Clinical trial NCT00855127: New Urine and Blood Markers for Acute Kidney Injury in Liver Transplant Patients
Official title: Early Biomarkers of Acute Kidney Injury in Liver Transplant Patients
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Renal Insufficiency, Acute
Keywords: Biological Markers
Renal Replacement Therapy
Mortality
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: University of Washington
name: Denver Health Medical Center
name: Children's Hospital Medical Center, Cincinnati
First posted: 2009-03-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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 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

Primary outcomes:
measure: Development of acute kidney injury as defined by a 50% increase in serum creatinine
timeFrame: Within 2 to 5 days of liver transplant that is sustained for at least 24 hours
Secondary outcomes:
measure: Development of severe acute kidney injury, as defined as a doubling of serum creatinine
timeFrame: Within 2-5 days of transplant that is sustained for at least 24 hours
measure: The need for renal replacement therapy
timeFrame: After liver transplant operation to discharge
measure: All cause mortality
timeFrame: After liver transplant operation to discharge
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Colorado, Denver
name: Angela M Walcher, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Denver
name: Charles L Edelstein, MD, PhD
role: STUDY_DIRECTOR
affiliation: University of Washington
name: Connie L Davis, MD
role: STUDY_DIRECTOR
References:
citation: 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.
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. doi: 10.1038/sj.ki.5001527. Epub 2006 May 17.
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. doi: 10.1681/ASN.2005030236. Epub 2005 Sep 7.