Treatment of Postoperative Atrial Fibrillation - Comparison of Amiodarone and Placebo.

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Post-operative atrial fibrillation (POAF) is the most common complication encountered after cardiac surgery; reports show POAF to occur in ~ 35% of patients after CABG. Prophylactic use amiodarone was found to be effective, however, due to serious extracardiac adverse effects therapy is probably appropriate just for patients at high risk for POAF.

the common practice for management of POAF is treatment with intravenous Amiodarone until return to sinus rhythm, following which the drug is given orally. Our protocol involves continued treatment with amiodarone for 30 day post-discharge from the hospital in a dose of 200mg per day.

This protocol is a common practice in many cardiac surgical departments worldwide, nevertheless, it is not evidence-based protocol and it was never examined as such.

This study is a randomized placebo controlled trial, to evaluate the requirement for post-discharge treatment with oral Amiodarone.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rambam Health Care Campus
• Treatments: Amiodarone

Criteria

Inclusion Criteria:

• All post-cardiac surgery patients who developed a hemodynamically stable postoperative atrial fibrillation and returned to sinus rhythm with intravenous amiodarone tretament.

Exclusion Criteria:

• Post-cardiac surgery patients who developed a non- hemodynamically stable postoperative atrial fibrillation.

• Patients with chronic and/or paroxysmal atrial fibrillation and/or known other cardiac arrhythmia or conduction disturbance.

• Patients with pacemakers.

• Patients with lactose intolerance