Urine Sample Processing Study

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05483088
• Other study ID #: Turquoise
• Status: Completed
• Start date: November 12, 2021
• Est. completion date: July 31, 2023

Study information

• Verified date: October 2023
• Source: Astute Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

Diagnostic Test:
• Urine collection for NEPHROCLEAR CCL14 Test
Urine will be collected for analysis with the NEPHROCLEAR CCL14 Test

Locations

Country	Name	City	State
United States	University of Maryland, Baltimore	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Astute Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stability of CCL14 in urine samples	Stability of CCL14 in urine samples as measured by the NEPHROCLEAR™ CCL14 Test	Up to 24 hours