A Sample Collection Study to Validate the Astute Medical NephroCheck Test in Critically Ill Subjects at Risk for Acute Kidney Injury
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Ages Eligible for Study:
21 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Adult patients at risk of AKI.
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.
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)