VIDAS® NEPHROCLEAR Diagnostic Accuracy Study

Acute Kidney Injury Clinical Trial

Official title:

VIDAS® NEPHROCLEAR CCL14 Diagnostic Accuracy Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06036758
• Other study ID #: B3166-CTPR02
• Status: Completed
• Start date: July 17, 2023
• Est. completion date: December 28, 2023

Study information

• Verified date: September 2023
• Source: BioMérieux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 477
• Est. completion date: December 28, 2023
• Est. primary completion date: December 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Acute Kidney Injury
• Wounds and Injuries

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
United States	University of Illinois	Chicago	Illinois
United States	George Washington University	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
BioMérieux

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk of developing persistent severe AKI	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	Within 48 hours of ICU admittance