Specimen Stability Study

Completed

Conditions studied: Acute Kidney Injury

In brief

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.

Key facts

Study ID

NCT01846884

Run by

Astute Medical, Inc.

People needed

124

Starts

2012-11-01

Expected to finish

2013-05-01

Last updated by the study team

2013-05-17

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — La Mesa, California, United States
• Study site — Honolulu, Hawaii, United States
• Study site — Idaho Falls, Idaho, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Port Jefferson, New York, United States
• Study site — Greenville, North Carolina, United States

Full record on ClinicalTrials.gov

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