Phase 4
N=260
Fish Oil for Reduction of Atrial Fibrillation After Cardiac Surgery
Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT00446966 ↗Enrolled (actual)
260
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcome: Primary: Number of Participants Who Developed Postoperative Atrial Fibrillation — 33; 30 participants — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Omega Three Polyunsaturated fatty acids (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Chirag Sandesara
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Developed Postoperative Atrial Fibrillation |
33; 30 | <0.01 sig |
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.
Data sourced from ClinicalTrials.gov (NCT00446966). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.