Fish Oil for Reduction of Atrial Fibrillation After Cardiac Surgery
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: Omega Three Polyunsaturated fatty acids
Intervention description: 2 grams orally twice daily pre-operatively and 2 grams orally daily after until primary endpoint or 14 days.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 260.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: atrial fibrillation; coronary artery disease bypass graft surgery

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.
    

Eligibility 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.