Identification and Validation of Biomarkers of Acute Kidney Injury Recovery
1 other identifier
observational
362
6 countries
21
Brief Summary
This study is to collect blood and urine samples to help identify and validate protein biomarkers of recovery from moderate or severe acute kidney injury (AKI).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2013
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2013
CompletedStudy Start
First participant enrolled
June 1, 2013
CompletedFirst Posted
Study publicly available on registry
June 4, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedMarch 13, 2015
September 1, 2014
1.3 years
May 21, 2013
March 12, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Validation of biomarkers for Acute Kidney Injury Recovery in Blood or Urine.
This study is a multi-center study intended to enroll enough subjects to validate biomarkers for acute kidney injury recovery. Subjects enrolled will be those with known moderate to severe AKI. The study is to determine the outcome of Major Adverse Kidney Event (MAKE) and Major Adverse Cardiac Event (MACE) during a period of up to 7 days.
Day 1-7 of enrollment
Secondary Outcomes (1)
None at this time
10 months
Eligibility Criteria
Adult ICU Patients with AKI
You may qualify if:
- Males and females 21 years of age or older
- 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)
You may not qualify if:
- Prior kidney transplantation
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Unknown Facility
Washington D.C., District of Columbia, 20037, United States
Unknown Facility
Gainesville, Florida, 32610, United States
Unknown Facility
Chicago, Illinois, 60611, United States
Unknown Facility
Chicago, Illinois, 60637, United States
Unknown Facility
Baltimore, Massachusetts, 21201, United States
Unknown Facility
Ann Arbor, Michigan, 48109, United States
Unknown Facility
Durham, North Carolina, 27705, United States
Unknown Facility
Akron, Ohio, 44304, United States
Unknown Facility
Cleveland, Ohio, 44195, United States
Unknown Facility
Pittsburgh, Pennsylvania, 15212, United States
Unknown Facility
Pittsburgh, Pennsylvania, 15261, United States
Unknown Facility
Nashville, Tennessee, 37232, United States
Unknown Facility
Innsbruck, 6020, Austria
Unknown Facility
Brussels, 1090, Belgium
Unknown Facility
Ghent, 9000, Belgium
Unknown Facility
Frankfurt, 60590, Germany
Unknown Facility
Madgeburg, 39120, Germany
Unknown Facility
Sabadelle, 08208, Spain
Unknown Facility
London, E1 1BB, United Kingdom
Unknown Facility
London, SE1 7EH, United Kingdom
Unknown Facility
West Sussex, BN11 2DH, United Kingdom
Related Publications (2)
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.
PMID: 35919538DERIVEDHoste 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.
PMID: 32025755DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lakhmir S Chawla, M.D.
George Washington University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2013
First Posted
June 4, 2013
Study Start
June 1, 2013
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
March 13, 2015
Record last verified: 2014-09