Specimen Stability Study
Completed
- Conditions
- Acute Kidney Injury
- Registration Number
- NCT01846884
- Lead Sponsor
- Astute Medical, Inc.
- Brief Summary
To collect and process urine samples from critically ill subjects for use in assessing the effects of various urine sample freezing and storage conditions on biomarker test results.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 124
Inclusion Criteria
-
Males and females 21 years of age or older
-
Subjects must be enrolled (first study-specific sample collection) within 24 hours of ICU admission
- Subjects enrolled from ED or Floor must be admitted to the ICU within 24 hours of enrollment
- Subjects enrolled in the ICU must have been admitted to the ICU or transferred into the study ICU from another ICU no more than 24 hours prior to enrollment
-
Expected to remain in the ICU for at least 48 hours after enrollment
-
Use of indwelling urinary catheter as standard care expected for at least 48 hours after enrollment
-
Subject (or authorized representative)able and willing to provide written informed consent for study participation
Exclusion Criteria
- Special populations including children, pregnant women, and prisoners
- Previous renal transplantation
- 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)
- Subjects with a history of chronic kidney disease (CKD) without a baseline serum creatinine value (baseline within 6 months of enrollment)
- Previously provided a urine sample and enrolled in this study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Specimen handling and stability, for example, effect of temperature on biomarker results. There are no primary clinical outcomes. 6 months
- Secondary Outcome Measures
Name Time Method