Acute Kidney Injury, Stage 2 Acute Kidney Injury, Stage 3 Acute Kidney Injury
Conditions
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.
Interventions
DIAGNOSTIC_TESTVIDAS® NEPHROCLEAR™ CCL14 Test
Urine samples previously collected from persons with stage 2/stage 3 AKI will be tested using the VIDAS® NEPHROCLEAR™ CCL14 Test
Sponsors
BioMérieux
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Risk of developing persistent severe AKI | Within 48 hours of ICU admittance | The urine sample collected from ICU patients will be tested using the VIDAS® NEPHROCLEAR™ CCL14 Test, which 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 |
Countries
United States
Outcome results
None listed