Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
477 participants
OBSERVATIONAL
2023-07-17
2023-12-28
Brief Summary
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Detailed Description
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The VIDAS® NEPHROCLEAR™ CCL14 Test is intended to be used in patients 21 years of age or older.
The objective of this study is to evaluate the diagnostic accuracy of the VIDAS® NEPHROCLEAR™ CCL14 test when used on the VIDAS® 3 instrument. Sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV), likelihood ratios (LR), and relative risk (RR), will be evaluated at the pre-determined cut-off values.
Previously collected urine samples from persons with Stage 2 to Stage 3 AKI will be tested in this study. The VIDAS® test results will be compared to the clinical AKI status established by independent adjudication by medical professionals, that are blinded to the VIDAS® test results.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Persons with Stage 2 to Stage 3 AKI
Persons with Stage 2 to Stage 3 AKI who are in the ICU.
VIDAS® NEPHROCLEAR™ CCL14 Test
Urine samples previously collected from persons with stage 2/stage 3 AKI will be tested using the VIDAS® NEPHROCLEAR™ CCL14 Test
Interventions
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VIDAS® NEPHROCLEAR™ CCL14 Test
Urine samples previously collected from persons with stage 2/stage 3 AKI will be tested using the VIDAS® NEPHROCLEAR™ CCL14 Test
Eligibility Criteria
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Inclusion Criteria
* 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
* 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;
21 Years
ALL
No
Sponsors
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BioMérieux
INDUSTRY
Responsible Party
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Locations
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George Washington University
Washington D.C., District of Columbia, United States
University of Illinois
Chicago, Illinois, United States
Countries
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Other Identifiers
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B3166-CTPR02
Identifier Type: -
Identifier Source: org_study_id
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