VIDAS® NEPHROCLEAR Diagnostic Accuracy Study (NCT06036758) | Clinical Trial Compass
CompletedNot Applicable
VIDAS® NEPHROCLEAR Diagnostic Accuracy Study
United States477 participantsStarted 2023-07-17
Plain-language summary
This is a multi-center sample analysis study in which urine samples previously collected from persons with Stage 2 or Stage 3 Acute Kidney Injury (AKI), will be tested in order to validate the VIDAS® NEPHROCLEAR™ CCL14 Test
Who can participate
Age range21 Years
SexALL
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Inclusion Criteria:
* 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 sample collection;
* Urine sample must be collected within 36 hours of meeting KDIGO Stage 2 criteria;
* Documented 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;
* Known infection with human immunodeficiency virus (HIV) or active hepatitis (acute or chronic); (NOTE: HIV or hepatitis testing need not be performed for enrollment in this study.)
* Special populations, pregnant women, prisoners or institutionalized individuals;