Prophylaxis to Reduce Postoperative Atrial Fibrillation in Cardiac Surgery

Completed · Phase 3

Conditions studied: Atrial Fibrillation, Atrial Flutter

In brief

Atrial Fibrillation (AF) is a common postoperative complication of cardiac surgery, occuring in approximately 25-30% of coronary artery bypass graft (CABG) patients and 35-40% of heart valve repair/replacement patients. Efforts to decrease the high rates of AF have not made great inroads to the problem. The current standard of care is the use of preoperative and postoperative beta blockers. We propose to compare the use of prophylactic oral ascorbic acid with and without prophylactic oral amiodarone, in combination with oral beta blockers, for the prevention of atrial fibrillation after open heart surgery. The hypothesis is that either drug, or a combination of the two drugs, will be superior and safe when compared to beta blockers alone.

Key facts

Study ID

NCT00953212

Run by

MaineHealth

People needed

304

Starts

2009-08-01

Expected to finish

2012-02-01

Last updated by the study team

2018-04-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• adults (18 years of age or older)
• all comers for elective or urgent open heart surgery ( CABG, Valve repair or replacement, Combined CABG/Valves, CABG/other, Other)

You may not qualify if…

• patients who refuse to participate
• patients with a history of atrial fibrillation or atrial flutter
• pediatric patients (under 18 years of age)
• Emergency surgery
• patients with contraindications to study medications
• patients with untreated thyroid disease, hepatic failure, pregnancy

Where it is running

• Maine Medical Center — Portland, Maine, United States

Full record on ClinicalTrials.gov

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