Clinical trial NCT06036758: VIDAS® NEPHROCLEAR Diagnostic Accuracy Study
Official title: VIDAS® NEPHROCLEAR CCL14 Diagnostic Accuracy Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Stage 2 Acute Kidney Injury
Stage 3 Acute Kidney Injury
Lead sponsor: BioMérieux
Sponsor class: INDUSTRY
First posted: 2023-09-14
Enrollment: 477
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Persons with Stage 2 to Stage 3 AKI

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® NEPHROCLEAR™ CCL14 Test

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 risk assessment for developing persistent severe AKI (stage 3 AKI lasting ≥ 72 hours) within 48 hours of patient assessment.

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Risk of developing persistent severe AKI
timeFrame: Within 48 hours of ICU admittance
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
city: Chicago
country: United States
facility: University of Illinois
state: Illinois
Study officials:
References: