Urine Sample Processing Study

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

  • Acute Kidney Injury

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