Identification and Validation of Biomarkers of Acute Kidney Injury Recovery
NCT ID: NCT01868724
Last Updated: 2015-03-13
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
362 participants
OBSERVATIONAL
2013-06-30
2014-09-30
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
* Receiving care in an intensive care unit
* Expected to remain in the ICU for at least 48 hours after enrollment
* Use of indwelling urinary catheter as standard care at the time of enrollment
* Subject must have acute kidney injury (KDIGO stage 2 or stage 3) at the time of the first sample collection
* First sample must be collected within 36 hours of meeting KDIGO stage 2 criteria
* Written informed consent provided by patient or legally authorized representative (LAR)
Exclusion Criteria
* Comfort-measures-only status
* Already receiving dialysis (either acute or chronic) or in imminent need of dialysis at the time of enrollment
* History of human immunodeficiency virus (HIV) or hepatitis virus (based upon available medical records) infections (NOTE: HIV or hepatitis testing need not be performed for enrollment in this study.)
* Special populations, pregnant women, prisoners or institutionalized individuals
* Patient meets any of the following:
* Active bleeding with an anticipated need for \> 4 units PRBC in a day
* Hemoglobin \< 7 g/dL
* Any other condition that in the physician's opinion would contraindicate drawing serial blood samples for clinical study purposes
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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Lakhmir S Chawla, M.D.
Role: PRINCIPAL_INVESTIGATOR
George Washington University
Locations
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Washington D.C., District of Columbia, United States
Gainesville, Florida, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Baltimore, Massachusetts, United States
Ann Arbor, Michigan, United States
Durham, North Carolina, United States
Akron, Ohio, United States
Cleveland, Ohio, United States
Pittsburgh, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Nashville, Tennessee, United States
Innsbruck, , Austria
Brussels, , Belgium
Ghent, , Belgium
Frankfurt, , Germany
Madgeburg, , Germany
Sabadelle, , Spain
London, , United Kingdom
London, , United Kingdom
West Sussex, , United Kingdom
Countries
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References
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Koyner JL, Chawla LS, Bihorac A, Gunnerson KJ, Schroeder R, Demirjian S, Hodgson L, Frey JA, Wilber ST, Kampf JP, Kwan T, McPherson P, Kellum JA; RUBY investigators. Performance of a Standardized Clinical Assay for Urinary C-C Motif Chemokine Ligand 14 (CCL14) for Persistent Severe Acute Kidney Injury. Kidney360. 2022 Mar 24;3(7):1158-1168. doi: 10.34067/KID.0008002021. eCollection 2022 Jul 28.
Hoste E, Bihorac A, Al-Khafaji A, Ortega LM, Ostermann M, Haase M, Zacharowski K, Wunderink R, Heung M, Lissauer M, Self WH, Koyner JL, Honore PM, Prowle JR, Joannidis M, Forni LG, Kampf JP, McPherson P, Kellum JA, Chawla LS; RUBY Investigators. Identification and validation of biomarkers of persistent acute kidney injury: the RUBY study. Intensive Care Med. 2020 May;46(5):943-953. doi: 10.1007/s00134-019-05919-0. Epub 2020 Feb 6.
Other Identifiers
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Ruby
Identifier Type: -
Identifier Source: org_study_id
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