Abstract: TH-OR016
EPACRA AKI: Primary Results of a Prospective Observational Study Establishing the ProNephro AKI Neutrophil Gelatinase-Associated Lipocalin Cutoff for Risk Stratification of Moderate-to-Severe AKI in Adult Patients in the Intensive Care Unit (ICU)
Session Information
- AKI Across the Care Continuum: From Detection to Recovery
October 22, 2026 | Location: Room 203, Convention Center
Abstract Time: 05:30 PM - 05:40 PM
Category: Acute Kidney Injury
- 102 AKI: Clinical, Outcomes, and Trials
Authors
- Allegretti, Andrew S., Massachusetts General Hospital, Boston, Massachusetts, United States
- Demirjian, Sevag, Cleveland Clinic, Cleveland, Ohio, United States
- Heung, Michael, University of Michigan, Ann Arbor, Michigan, United States
- Koyner, Jay L., The University of Chicago, Chicago, Illinois, United States
- McMahon, Blaithin A., Medical University of South Carolina, Charleston, South Carolina, United States
- Morrissey, Brian, University of California Davis, Davis, California, United States
- Neyra, Javier A., The University of Alabama at Birmingham, Birmingham, Alabama, United States
- Srialluri, Nityasree, Johns Hopkins Medicine, Baltimore, Maryland, United States
- Teixeira, J. Pedro, The University of New Mexico, Albuquerque, New Mexico, United States
- Wagener, Gebhard, Columbia University, New York, New York, United States
- Wilson, Francis Perry, Yale School of Medicine, New Haven, Connecticut, United States
- Devarajan, Prasad, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
Background
AKI s a common clinical event with severe consequences resulting in increased risk of mortality, morbidity and prolonged hospital stays. Expression of the Neutrophil Gelatinase Associated lipocalin (NGAL) protein is dramatically increased in the distal tubule almost immediately after kidney injury and is rapidly released into urine, making NGAL an early and sensitive biomarker to recognize structural kidney injury in real time. The EPACRA-AKI study aimed to establish an optimal cutoff for the ProNephro AKITM (NGAL) assay to predict patients at risk for AKI in the general adult population 48 to 72 hours after ICU admission.
Methods
Observational study with collection of urine within 24 hours of ICU admission conducted at 12 US academic medical centers and 1 testing site. Samples were tested on a single cobas c501 clinical chemistry analyzer with the ProNephro AKITM (NGAL) urine assay. Primary outcome was diagnosis of AKI stage 2/3 at 48-72 hours after ICU admission as defined by the 2012 KDIGO AKI serum creatinine staging definitions. AKI was determined by an independent adjudication panel of three clinicians with expertise in diagnosis of AKI who were blinded to NGAL results.
Results
444 subjects met criteria for adjudication. 47 subjects developed as AKI stage 2/3 (prevalence 10.8%). Median age was 65 years (mean 62.4, range 22-99) with 62.4% male. Most common ICU admission diagnoses were respiratory (22.7%) and cardiovascular (18.0%) failure. By Youden's index, the cut-off that optimized NGAL for sensitivity and specificity was 172 ng/mL, which resulted in a sensitivity of 63.8% and specificity of 81.6% and an AUC of 0.771 (95% CI 0.695, 0.848; see Table).
Conclusion
At an optimal cut point of 172 ng/mL, urine NGAL drawn within 24 hours of ICU admission provided excellent discrimination for the diagnosis of persistent stage 2/3 AKI 48 to 72 hours after ICU admission. Clinicaltrials.gov NCT06652100
| AKI | No AKI | Total | |
| NGAL ≥172 ng/dL | 30 | 73 | 103 |
| NGAL <172 ng/dL | 17 | 324 | 341 |
| Total | 47 | 397 | 444 |
| Youden's Index | 45.44% | Area Under the Curve (95% CI) | 0.771 (0.694, 0.848) |
| Sensitivity (95% CI) | 63.83% (48.52%, 77.33%) | Specificity (95% CI) | 81.61% (77.44%, 85.30%) |
| Positive Predictive Value (95% CI) | 29.13% (20.59%, 38.90%) | Negative Predictive Value (95% CI) | 95.01% (92.14%, 97.07%) |
Funding
- Commercial Support – Bioporto Diagnostics