Identification and Validation of Biomarkers of Acute Kidney Injury Recovery

Inclusion Criteria:a.

- Males and females 21 years of age or older

- Receiving care in an intensive care unit

- Expected to remain in the ICU for at least 48 hours after enrollment

- Use of indwelling urinary catheter as standard care at the time of enrollment

- Subject must have acute kidney injury (KDIGO stage 2 or stage 3) at the time of the
first sample collection

- First sample must be collected within 36 hours of meeting KDIGO stage 2 criteria

- Written informed consent provided by patient or legally authorized representative
(LAR)

Exclusion Criteria:

- Prior kidney transplantation

- Comfort-measures-only status

- Already receiving dialysis (either acute or chronic) or in imminent need of dialysis
at the time of enrollment

- History of human immunodeficiency virus (HIV) or hepatitis virus (based upon
available medical records) infections (NOTE: HIV or hepatitis testing need not be
performed for enrollment in this study.)

- Special populations, pregnant women, prisoners or institutionalized individuals

- Patient meets any of the following:

- Active bleeding with an anticipated need for > 4 units PRBC in a day

- Hemoglobin < 7 g/dL

- Any other condition that in the physician's opinion would contraindicate drawing
serial blood samples for clinical study purposes