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Clinical Trials/NCT01846884
NCT01846884CompletedNot Applicable

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

Astute Medical, Inc.0 sites124 target enrollmentStarted: November 2012Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
124
Primary Endpoint
Specimen handling and stability, for example, effect of temperature on biomarker results. There are no primary clinical outcomes.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
21 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Specimen handling and stability, for example, effect of temperature on biomarker results. There are no primary clinical outcomes.

Time Frame: 6 months

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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