Fish Oil for Reduction of Atrial Fibrillation After Cardiac Surgery

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to determine if omega-3 polyunsaturated fatty acids reduce atrial fibrillation and other outcomes after cardiac surgery. In this placebo-controlled trial, patients undergoing elective coronary artery bypass graft surgery with or without valve repair will be treated with omega-3 polyunsaturated fatty acids perioperatively. The following hypotheses will be tested: 1. omega-3 polyunsaturated fatty acids reduces the incidence of atrial fibrillation (AF) after cardiac surgery, 2. omega-3 polyunsaturated fatty acids, administered in the perioperative period for cardiac surgery, decreases postoperative complication rates, and 3. omega-3 polyunsaturated fatty acids decrease intensive care unit and hospital length-of-stay.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Chirag Sandesara; University of Iowa
• Collaborator: GlaxoSmithKline

Criteria

Inclusion Criteria:

• Age 18-85 years old.

• Elective coronary artery bypass (CABG) operation with or without concomitant valve surgery planned for at least 2 days after enrollment.

• Signed, documented informed consent prior to admission to the study.

Exclusion Criteria:

• Urgent or emergent bypass required to be performed <24 hrs after screening.

• Unstable angina, requiring intervention or CABG <24 hrs after screening.

• Decompensated congestive heart failure.

• Chronic, persistent atrial fibrillation - patient in atrial fibrillation at the time of screening or enrollment or scheduled for a maze procedure or pulmonary vein isolation at the time of surgery.

• Known sensitivity to Omacor (0mega-3 acid ethyl esters) and hypersensitivity to fish, fish products or corn oil.

• Patients requiring warfarin or Lovenox the 2 days prior to bypass surgery.

• Patients on Class I or III antiarrhythmic agents (quinidine, procainamide, disopyramide, flecainide, propafenone, moricizine, dofetilide, sotalol, amiodarone) or who have taken these drugs within 5 elimination half-lives of the drug (or within 2 months for amiodarone).

• Patients who are pregnant or nursing.

• Patients unable to provide/sign informed consent.

• Patients currently enrolled in another clinical trial without a 30 day washout period.

• Patients currently taking marine based omega-three fish oil supplements.