Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
110 participants
OBSERVATIONAL
2021-11-12
2023-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with KDIGO stage 2 or 3 AKI
Urine collection for NEPHROCLEAR CCL14 Test
Urine will be collected for analysis with the NEPHROCLEAR CCL14 Test
Interventions
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Urine collection for NEPHROCLEAR CCL14 Test
Urine will be collected for analysis with the NEPHROCLEAR CCL14 Test
Eligibility Criteria
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Inclusion Criteria
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
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.
21 Years
ALL
No
Sponsors
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Astute Medical, Inc.
INDUSTRY
Responsible Party
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Locations
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University of Maryland, Baltimore
Baltimore, Maryland, United States
Countries
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Other Identifiers
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Turquoise
Identifier Type: -
Identifier Source: org_study_id
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