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Purpose

The objective of the study is to collect and process urine samples from Intensive Care Unit (ICU) subjects with moderate to severe (Stage 2 or 3) acute kidney injury (AKI) for use in assessing the effects of urine sample freezing and various storage conditions on NEPHROCLEAR™ CCL14 Test results. This study is observational and will have no impact on the medical management of the subject.

Condition

Eligibility

Eligible Ages
Over 21 Years
Eligible Genders
All
Accepts 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.

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Patients with KDIGO stage 2 or 3 AKI
  • Diagnostic Test: Urine collection for NEPHROCLEAR CCL14 Test
    Urine will be collected for analysis with the NEPHROCLEAR CCL14 Test

More Details

Status
Completed
Sponsor
Astute Medical, Inc.

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.