A Sample Collection Study to Validate the Astute Medical NephroCheck Test in Critically Ill Subjects at Risk for Acute Kidney Injury
NCT ID: NCT01573962
Last Updated: 2014-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
420 participants
OBSERVATIONAL
2012-04-30
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* At least one of the following acute conditions documented within 24 hours prior to enrollment
* Respiratory SOFA score of ≥ 2 (PaO2/FiO2 \<300)
* Cardiovascular SOFA score of ≥ 1 (MAP \< 70 mm Hg and/or any vasopressor required
* Subject (or authorized representative) able and willing to provide written informed consent for study participation.
Exclusion Criteria
* Previous renal transplantation
* Known moderate to severe AKI prior to enrollment (e.g., RIFLE-I or RIFLE-F/ AKIN 2 or AKIN 3
* 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)
21 Years
ALL
No
Sponsors
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Astute Medical, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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John Kellum, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Professor, Critical Care Medicine, University of Pittsburgh
Locations
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Loma Linda, California, United States
Los Angels, California, United States
Washington D.C., District of Columbia, United States
Gainesville, Florida, United States
Tampa, Florida, United States
Idaho Falls, Idaho, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Shreveport, Louisiana, United States
Baltimore, Maryland, United States
Ann Arbor, Michigan, United States
Minneapolis, Minnesota, United States
Missoula, Montana, United States
Rochester, New York, United States
The Bronx, New York, United States
Durham, North Carolina, United States
Akron, Ohio, United States
Portland, Oregon, United States
Pittsburgh, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Nashville, Tennessee, United States
Houston, Texas, United States
Richmond, Virginia, United States
Countries
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References
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Bihorac A, Chawla LS, Shaw AD, Al-Khafaji A, Davison DL, Demuth GE, Fitzgerald R, Gong MN, Graham DD, Gunnerson K, Heung M, Jortani S, Kleerup E, Koyner JL, Krell K, Letourneau J, Lissauer M, Miner J, Nguyen HB, Ortega LM, Self WH, Sellman R, Shi J, Straseski J, Szalados JE, Wilber ST, Walker MG, Wilson J, Wunderink R, Zimmerman J, Kellum JA. Validation of cell-cycle arrest biomarkers for acute kidney injury using clinical adjudication. Am J Respir Crit Care Med. 2014 Apr 15;189(8):932-9. doi: 10.1164/rccm.201401-0077OC.
Other Identifiers
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Topaz
Identifier Type: -
Identifier Source: org_study_id
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