Evaluation of Neutrophil Gelatinase-associated Lipocalin (NGAL) in Early and Evolving Acute Kidney Injury

Completed

Conditions studied: Kidney Failure, Acute

In brief

Some patients who undergo cardiovascular surgery requiring cardiopulmonary bypass will develop a kidney injury following their surgery. The purpose of this study is to take a blood sample from patients before they have this type of surgery and then at nine time points after their surgery to test their plasma for a biomarker called NGAL and compare the NGAL levels to their creatinine levels. We hypothesize that NGAL is an earlier marker for kidney injury than creatinine.

Key facts

Study ID

NCT00445809

Run by

Abbott RDx Cardiometabolic

People needed

355

Starts

2007-02-01

Expected to finish

2009-04-01

Last updated by the study team

2009-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Age < 18 years
• Inability to obtain Informed Consent from patient or representative
• Prisoners or other institutionalized or vulnerable individuals
• Participation in an interventional clinical study within the previous 30 days
• History of previous renal transplantation
• Stage 5 chronic kidney disease (estimated GRF<15 mL/min/1.73m2) (See Appendix C)
• Known or suspected ongoing pre-operative acute renal failure due to any cause, including pre-renal, intrinsic renal or post-renal (obstructive) etiologies (as evidenced by increasing serum creatinines or oliguria pre-operatively)
• Already receiving dialysis, in imminent need of dialysis or considered highly likely to need dialysis in the immediate post-operative period for fluid management
• Any known or suspected renal ischemic insult(such as cardiac arrest)or nephrotoxic insult(other than intravascular contrast procedure) during the 48 hours prior to surgery
• Known or suspected infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV)infection, hepatitis B virus (HBV) infection or other infectious hepatitis
• Pre-operative hematocrit <25%, recent blood transfusions have been administered to maintain hematocrit >25% or any other contraindication to obtaining the study-specified blood samples
• Undergoing cardiac transplantation

Where it is running

• St. Anthony's Central Hospital — Denver, Colorado, United States
• George Washington University — Washington D.C., District of Columbia, United States
• Maine Medical Center — Portland, Maine, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• St. Peters Healthcare — Albany, New York, United States
• New York Methodist — Brooklyn, New York, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• University of Texas, Houston — Houston, Texas, United States
• University of British Columbia — Vancouver, British Columbia, Canada

Full record on ClinicalTrials.gov

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