Status:
UNKNOWN
A Sample Collection Study to Validate the NEPHROCLEAR™ CCL14 Test
Lead Sponsor:
Astute Medical, Inc.
Conditions:
Acute Kidney Injury
Eligibility:
All Genders
21+ years
Brief Summary
The objective of this sample collection study is to collect urine samples to validate the NEPHROCLEAR™ CCL14 Test in patients with KDIGO stage 2 or 3 AKI. This study is observational and will have no ...
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);
- Special populations, pregnant women, prisoners or institutionalized individuals.
Key Trial Info
Start Date :
June 8 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04785391
Start Date
June 8 2021
End Date
December 1 2022
Last Update
July 20 2022
Active Locations (1)
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1
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15261