Urine Sample Processing Study

NCT05483088 | Completed FDA Device

• 1 other identifier: Turquoise
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Stability of CCL14 in urine samples

  Stability of CCL14 in urine samples as measured by the NEPHROCLEAR™ CCL14 Test

  Up to 24 hours

Study Arms (1)

Patients with KDIGO stage 2 or 3 AKI

Diagnostic Test: Urine collection for NEPHROCLEAR CCL14 Test

Interventions

Urine collection for NEPHROCLEAR CCL14 Test DIAGNOSTIC_TEST

Urine will be collected for analysis with the NEPHROCLEAR CCL14 Test

Patients with KDIGO stage 2 or 3 AKI

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult ICU patients with KDIGO stage 2 or 3 AKI.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Astute Medical, Inc.: lead

Study Sites (1)

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Urine Specimen Collection

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2022
• First Posted: August 1, 2022
• Study Start: November 12, 2021
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: October 26, 2023

Record last verified: 2023-10

Locations

US (1)