Does anti-inflammatory and anti-arrhythmic medical management prevent atrial fibrillation after heart surgery?
Phase 1
- Conditions
- new onset atrial fibrillation and paroxysmal atrial fibrillationTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2018-001430-18-FI
- Lead Sponsor
- Kuopio University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 240
Inclusion Criteria
Coronary artery bypass surgery or aortic valve surgery, adult, willing to participate,
not in chronic atrial fibrillation preoperatively
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120
Exclusion Criteria
not willing to participate, insulin dependent diabetes, active peptic ulcer, oversensitivity or allergy to hydrocortison or metoprolol, chronic atrial fibrillation,
psychosis, prolonged stay in intensive care unit postoperatively
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The main objective of the trial is to investigate whether postoperative corticosteroid and betablocker management prevents new-onset atrial fibrillation or<br>activation of paroxysmal atrial fibrallation immediately after coronary artery bypass surgery and aortic valve surgery.;Secondary Objective: Not applicable;Primary end point(s): Patient stays in sinus rhythm for three days postoperatively or<br>patient gets atrial fibrillation during first three postoperative days.;Timepoint(s) of evaluation of this end point: Three postoperative days
- Secondary Outcome Measures
Name Time Method Secondary end point(s): none;Timepoint(s) of evaluation of this end point: none