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Urine NGAL Predicts Severity of Acute Kidney Injury After Cardiac Surgery: A Prospective Study

Michael Bennett^*, Catherine L. Dent, Qing Ma^*, Sudha Dastrala^*, Frank Grenier, Ryan Workman, Hina Syed, Salman Ali, Jonathan Barasch, and Prasad Devarajan^*

^* Nephrology & Hypertension and, Cardiology, Cincinnati Children's Hospital Medical Center, University of Cincinnati School of Medicine, Cincinnati, Ohio; Abbott Diagnostics, Abbott Park, Illinois; and Nephrology, College of Physicians and Surgeons, Columbia University, New York, New York

Correspondence: Dr. Prasad Devarajan, Nephrology & Hypertension, MLC 7022, 3333 Burnet Avenue, Cincinnati, OH 45229-3039. Phone: 513-636-4531; Fax: 513-636-7407; E-mail: prasad.devarajan{at}cchmc.org

Background and objectives: The authors have previously shown that urine neutrophil gelatinase-associated lipocalin (NGAL), measured by a research ELISA, is an early predictive biomarker of acute kidney injury (AKI) after cardiopulmonary bypass (CPB). In this study, whether an NGAL immunoassay developed for a standardized clinical platform (ARCHITECT analyzer®, Abbott Diagnostics Division, Abbott Laboratories, Abbott Park, IL) can predict AKI after CPB was tested.

Design, setting, participants, & measurements: In a pilot study with 136 urine samples (NGAL range, 0.3 to 815 ng/ml) and 6 calibration standards (NGAL range, 0 to 1000 ng/ml), NGAL measurements by research ELISA and by the ARCHITECT® assay were highly correlated (r = 0.99). In a subsequent study, 196 children undergoing CPB were prospectively enrolled and serial urine NGAL measurements obtained by ARCHITECT® assay. The primary outcome was AKI, defined as a 50% increase in serum creatinine.

Results: AKI developed in 99 patients (51%), but the diagnosis using serum creatinine was delayed by 2 to 3 d after CPB. In contrast, mean urine NGAL levels increased 15-fold within 2 h and by 25-fold at 4 and 6 h after CPB. For the 2-h urine NGAL measurement, the area under the curve was 0.95, sensitivity was 0.82, and the specificity was 0.90 for prediction of AKI using a cutoff value of 100 ng/ml. The 2-h urine NGAL levels correlated with severity and duration of AKI, length of stay, dialysis requirement, and death.

Conclusions: Accurate measurements of urine NGAL are obtained using the ARCHITECT® platform. Urine NGAL is an early predictive biomarker of AKI severity after CPB.