Status:
COMPLETED
VIDAS® NEPHROCLEAR Diagnostic Accuracy Study
Lead Sponsor:
BioMérieux
Conditions:
Acute Kidney Injury
Stage 2 Acute Kidney Injury
Eligibility:
All Genders
21+ years
Brief 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® ...
Detailed Description
The VIDAS® NEPHROCLEAR™ CCL14 Test is intended to be used in conjunction with clinical evaluation, in ICU patients with moderate to severe (stage 2 or 3) acute kidney injury (AKI), as an aid in the ri...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
July 17 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 28 2023
Estimated Enrollment :
477 Patients enrolled
Trial Details
Trial ID
NCT06036758
Start Date
July 17 2023
End Date
December 28 2023
Last Update
February 28 2024
Active Locations (2)
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1
George Washington University
Washington D.C., District of Columbia, United States, 20052
2
University of Illinois
Chicago, Illinois, United States, 60612