Status:
COMPLETED
VIDAS Nephroclear (NCL) CCL14 - Sample Stability
Lead Sponsor:
BioMérieux
Conditions:
Acute Kidney Injury
Eligibility:
All Genders
21+ years
Brief Summary
This VIDAS® NEPHROCLEAR™ CCL14 (VIDAS® NCL™ CCL14) Sample Stability clinical trial is a multicenter, prospective, and qualitative study. The main study objective is to determine sample stability condi...
Detailed Description
Product name and intended use 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 inj...
Eligibility Criteria
Inclusion
- 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;
- Written informed consent provided by patient or legally authorized representative (LAR).
Exclusion
- 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 will not be performed for enrollment in this study.)
- Special populations, pregnant women, prisoners or institutionalized individuals;
Key Trial Info
Start Date :
March 10 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 31 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05271617
Start Date
March 10 2022
End Date
July 31 2023
Last Update
September 11 2023
Active Locations (1)
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1
East Carolina University
Greenville, North Carolina, United States, 27834