A Sample Collection Study to Validate the Astute Medical NephroCheck Test in Critically Ill Subjects at Risk for Acute Kidney Injury

Inclusion criteria

• Males and females 21 years of age or older
• Subjects must be enrolled (first study-specific sample collection) within 24 hours of ICU admission
• Subjects enrolled from ED or Floor must be admitted to the ICU within 24 hours of enrollment
• Subjects enrolled in the ICU must have been admitted to the ICU or transferred into the study ICU from another ICU no more than 24 hours prior to enrollment
• Expected to remain in the ICU for at least 48 hours after enrollment
• Use of indwelling urinary catheter as standard care expected for at least 48 hours after enrollment
• At least one of the following acute conditions documented within 24 hours prior to enrollment
• Respiratory SOFA score of ≥ 2 (PaO2/FiO2 <300)
• Cardiovascular SOFA score of ≥ 1 (MAP < 70 mm Hg and/or any vasopressor required
• Subject (or authorized representative) able and willing to provide written informed consent for study participation.

Exclusion criteria

• Special populations including women with known pregnancy, prisoners or institutionalized individuals
• Previous renal transplantation
• Known moderate to severe AKI prior to enrollment (e.g., RIFLE-I or RIFLE-F/ AKIN 2 or AKIN 3
• Already receiving dialysis (either acute or chronic) or in imminent need of dialysis at the time of enrollment
• Known infection with human immunodeficiency virus (HIV) or active hepatitis (acute or chronic)
• Subjects with a history of Chronic Kidney Disease (CKD) without a baseline serum creatinine value (baseline within 6 months of enrollment)