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OpenTrials
Completed

NCT Number: NCT01846884

Specimen Stability Study

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.

Completed

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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

La Mesa, California, United States

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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
  • 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

Treatment and study plan

Primary outcomes

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

    Time frame: 6 months

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 Critically Ill Subjects

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 6, 2013
Registry last updated
May 17, 2013

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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