Study Stopped
Study has been completed as planned
Corticosteroids for the Prevention of Atrial Fibrillation After Cardiac Surgery
Feasibility of Corticosteroid in the Prevention of Atrial Fibrillation After Cardiac Surgery: A Prospective, Double-Blind Randomized Multicenter Trial
1 other identifier
interventional
1
0 countries
N/A
Brief Summary
Atrial fibrillation is the most common arrhythmia to occur after cardiac surgery. Inflammatory response may be one etiological factor. We hypothesized that intravenous corticosteroid administration after cardiac surgery prevents AF after cardiac surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable atrial-fibrillation
Started Oct 2012
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2007
CompletedFirst Posted
Study publicly available on registry
March 2, 2007
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedNovember 16, 2012
October 1, 2012
Same day
March 1, 2007
November 15, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Study couldn´t start due to investigator
Study couldn´t start due to investigator
Study couldn´t start due to investigator
Secondary Outcomes (1)
Study couldn´t start due to investigator
Study couldn´t start due to investigator
Other Outcomes (1)
Study couldn´t start due to investigator
Study couldn´t start due to investigator
Study Arms (1)
Study couldn´t start due to investigator
OTHERStudy couldn´t start due to investigator
Interventions
Eligibility Criteria
You may qualify if:
- Patients scheduled to undergo their first on-pump CABG, aortic valve replacement or combined aortic valve replacement and CABG were enrolled.
You may not qualify if:
- Previous episodes of AF or flutter
- Uncontrolled diabetes mellitus
- Systemic mycotic infection
- Active tuberculosis
- Cushing's syndrome
- Psychotic mental disorder
- Herpes Simplex keratitis
- Serum creatinine exceeding 200 µg/ml
- Patients were also excluded if they had a history of previous peptic ulcer or thrombophlebitis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kuopio University Hospitallead
- Tampere University Hospitalcollaborator
- Oulu University Hospitalcollaborator
Related Publications (2)
Voltarelli JC, Couri CE, Stracieri AB, Oliveira MC, Moraes DA, Pieroni F, Coutinho M, Malmegrim KC, Foss-Freitas MC, Simoes BP, Foss MC, Squiers E, Burt RK. Autologous nonmyeloablative hematopoietic stem cell transplantation in newly diagnosed type 1 diabetes mellitus. JAMA. 2007 Apr 11;297(14):1568-76. doi: 10.1001/jama.297.14.1568.
PMID: 17426276DERIVEDHalonen J, Halonen P, Jarvinen O, Taskinen P, Auvinen T, Tarkka M, Hippelainen M, Juvonen T, Hartikainen J, Hakala T. Corticosteroids for the prevention of atrial fibrillation after cardiac surgery: a randomized controlled trial. JAMA. 2007 Apr 11;297(14):1562-7. doi: 10.1001/jama.297.14.1562.
PMID: 17426275DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jari Halonen, MD
Kuopio University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant
Study Record Dates
First Submitted
March 1, 2007
First Posted
March 2, 2007
Study Start
October 1, 2012
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
November 16, 2012
Record last verified: 2012-10