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)