Urine Sample Processing Study

Completed

• Conditions: Acute Kidney Injury
• Interventions: Diagnostic Test: Urine collection for NEPHROCLEAR CCL14 Test

• Registration Number: NCT05483088
• Lead Sponsor: Astute Medical, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-12
• Study First Submitted: 2022-07-29
• Study First Submitted QC: 2022-07-29
• Study First Posted: 2022-08-01
• Primary Completion: 2023-07-31
• Study Completion: 2023-07-31
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-25
• Last Update Posted: 2023-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with KDIGO stage 2 or 3 AKI	Urine collection for NEPHROCLEAR CCL14 Test	-

Primary Outcome Measures

Name	Time	Method
Stability of CCL14 in urine samples	Up to 24 hours	Stability of CCL14 in urine samples as measured by the NEPHROCLEAR™ CCL14 Test

Trial Locations

Locations (1)

University of Maryland, Baltimore; 🇺🇸 Baltimore, Maryland, United States