Urine Sample Processing Study: Analysis of Fresh Versus Frozen Urine Samples From ICU Subjects

Astute Medical, Inc.1 site in 1 country110 target enrollmentNovember 12, 2021

ConditionsAcute Kidney Injury

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Acute Kidney Injury
Sponsor: Astute Medical, Inc.
Enrollment: 110
Locations: 1
Primary Endpoint: Stability of CCL14 in urine samples
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

November 12, 2021

End Date

July 31, 2023

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Astute Medical, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•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.