VIDAS® NEPHROCLEAR Diagnostic Accuracy Study

Completed

• Conditions: Acute Kidney Injury; Stage 2 Acute Kidney Injury; Stage 3 Acute Kidney Injury
• Interventions: Diagnostic Test: VIDAS® NEPHROCLEAR™ CCL14 Test

• Registration Number: NCT06036758
• Lead Sponsor: BioMérieux

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.

Study Timeline

• Study Start: 2023-07-17
• Status Verified: 2023-09
• Study First Submitted: 2023-09-07
• Study First Submitted QC: 2023-09-07
• Study First Posted: 2023-09-14
• Primary Completion: 2023-12-28
• Study Completion: 2023-12-28
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 477

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;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Persons with Stage 2 to Stage 3 AKI	VIDAS® NEPHROCLEAR™ CCL14 Test	Persons with Stage 2 to Stage 3 AKI who are in the ICU.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

George Washington University; 🇺🇸 Washington, District of Columbia, United States

University of Illinois; 🇺🇸 Chicago, Illinois, United States