ProNephro NGAL Test for Early Detection of Acute Kidney Injury in Adult ICU Patients (ALPACA)

Inclusion criteria

Males and females ≥ 22 years of age. Subjects must be admitted or admission pending to an Intensive Care Unit and must have a urine sample collected within 24 hours of ICU admission.

Subjects must have at least one of the following, leading to admission to the ICU, or occurring within 24 hours of admission to the ICU (unless otherwise specified):

• Vasoactive medication administration
• Mechanical ventilation
• Hypoxemia requiring oxygen support therapy including Bilevel positive airway pressure (BIPAP) and high flow nasal canula
• Serum Lactate greater than 2.5 mmol/L, within 6 hours prior to enrollment
• History (any) of solid organ transplantation, renal transplantation included only if more than 3 months prior

Exclusion criteria

Special populations including pregnant and lactating women, prisoners, or institutionalized individuals.

Subjects receiving Kidney Replacement Therapy in the first 24 hours of ICU admission.

Subjects diagnosed with active Urinary Tract Infection per institute standard of care at the time of NGAL sampling.

Subjects with a known history of chronic kidney disease stages 4 or 5 as evidenced by a pre-enrollment estimated GFR of less than 30 mL/min/1.73m2

Subjects with any known urothelial, urological or kidney malignancies.

Subjects that have had any of the following urologic procedure or urologic surgery within 30 days prior to ICU admission: Nephrostomy or nephroureteral stent placement; ureteral stent placement or exchange; ureteroscopy; lithotripsy; transurethral resection of the prostate; transurethral resection of bladder tumor; or renal biopsy.

Subjects that have had surgical nephrectomy less than 3 months prior to admission.

Subjects that have been previously enrolled in this study.

Subjects enrolled in an interventional pharmaceutical or device clinical trial ICU admission.