Acute Kidney Injury
Conditions
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 impact on the medical management of the subject.
Interventions
DIAGNOSTIC_TESTUrine collection for NEPHROCLEAR CCL14 Test
Urine will be collected and banked for future analysis with the NEPHROCLEAR CCL14 Test
Sponsors
Astute Medical, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Males and females 21 years of age or older; 2. Receiving care in an intensive care unit; 3. Expected to remain in the ICU for at least 48 hours after enrollment; 4. Use of indwelling urinary catheter as standard care at the time of enrollment; 5. Subject must have acute kidney injury (KDIGO Stage 2 or Stage 3) at the time of sample collection; 6. Urine sample must be collected within 36 hours of meeting KDIGO Stage 2 criteria; 7. Written informed consent provided by patient or legally authorized representative (LAR).
Exclusion criteria
1. Prior kidney transplantation; 2. Comfort-measures-only status; 3. Already receiving dialysis (either acute or chronic) or in imminent need of dialysis at the time of enrollment; 4. Known infection with human immunodeficiency virus (HIV) or active hepatitis (acute or chronic); 5. Special populations, pregnant women, prisoners or institutionalized individuals.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Persistent Severe Acute Kidney Injury as Determined by Physician Adjudication | Within 5 days |
Countries
United States
Contacts
Primary ContactClinical Trials Manager
Outcome results
None listed