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Specimen Stability Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01846884
Recruitment Status : Completed
First Posted : May 6, 2013
Last Update Posted : May 17, 2013
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Acute Kidney Injury

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Study Type : Observational
Actual Enrollment : 124 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Urine Sample Processing Study:Analysis of Fresh Versus Frozen Urine Samples From Critically Ill Subjects
Study Start Date : November 2012
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Specimen handling and stability, for example, effect of temperature on biomarker results. There are no primary clinical outcomes. [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Critically-ill adult subjects at risk for acute kidney injury.
Criteria

Inclusion Criteria:

  1. Males and females 21 years of age or older
  2. 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
  3. Expected to remain in the ICU for at least 48 hours after enrollment
  4. Use of indwelling urinary catheter as standard care expected for at least 48 hours after enrollment
  5. Subject (or authorized representative)able and willing to provide written informed consent for study participation

Exclusion Criteria:

  1. Special populations including children, pregnant women, and prisoners
  2. Previous renal transplantation
  3. Already receiving dialysis (either acute or chronic) or in imminent need of dialysis at the time of enrollment
  4. Known infection with human immunodeficiency virus (HIV) or active hepatitis (acute or chronic)
  5. Subjects with a history of chronic kidney disease (CKD) without a baseline serum creatinine value (baseline within 6 months of enrollment)
  6. Previously provided a urine sample and enrolled in this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01846884


Locations
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United States, California
La Mesa, California, United States, 91942
United States, Hawaii
Honolulu, Hawaii, United States, 96813
United States, Idaho
Idaho Falls, Idaho, United States, 83404
United States, Nevada
Las Vegas, Nevada, United States, 89109
United States, New York
Port Jefferson, New York, United States, 11777
United States, North Carolina
Greenville, North Carolina, United States, 27834
Sponsors and Collaborators
Astute Medical, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Astute Medical, Inc.
ClinicalTrials.gov Identifier: NCT01846884    
Other Study ID Numbers: Opal
First Posted: May 6, 2013    Key Record Dates
Last Update Posted: May 17, 2013
Last Verified: May 2013
Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases