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Clinical Trials/NCT05483088
NCT05483088
Completed
Not Applicable

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

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

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

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.

Outcomes

Primary Outcomes

Stability of CCL14 in urine samples

Time Frame: Up to 24 hours

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

Study Sites (1)

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