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Completed

NCT Number: NCT05483088

Urine Sample Processing Study

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.

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Urine collection for NEPHROCLEAR CCL14 Test

Diagnostic Test

Urine will be collected for analysis with the NEPHROCLEAR CCL14 Test

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Astute Medical, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 1, 2022
Registry last updated
Oct 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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