Omega 3 Fatty Acid Efficiency for Prevention of Atrial Fibrillation After Coronary Artery Bypass Grafting

Study Overview
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Brief Summary
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The purpose of this study is to evaluate efficacy of Polyunsaturated Fatty Acid for the prevention of Atrial Fibrillation and anti-inflammatory effects in patients after CABG surgery

Official Title
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Randomized Trial of Fish Oil Infusion to Prevent Atrial Fibrillation After Cardiac Surgery

Conditions
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Ischemic Heart Disease, Atrial Fibrillation

Intervention / Treatment
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* Drug: Omega-3 fish oil emulsion (Omegaven)
* Drug: Intralipid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elective CABG surgery. Signed, documented informed consent prior to admission to the study. Exclusion Criteria: Unstable angina, requiring intervention or CABG <24 hrs after screening. Decompensated congestive heart failure. Chronic, persistent, paroxysmal atrial fibrillation. Uncorrected significant valvular heart disease Known hypersensitivity to the study drug Left ventricular dysfunction (ejection fraction <35%) Use of anti-arrhythmic drugs other than beta blockers Non-cardiac illness with a life expectancy of less than 1 year Bleeding diathesis or history of coagulopathy Significant renal and liver insufficiency Significant thyroid, pulmonary disease Uncontrolled diabetes mellitus Patients on anti-arrhythmic drugs Patients with pacemaker Patients unable to provide/sign informed consent. Patients currently taking marine based omega-three fish oil supplements. Disturbances in lipid metabolism, serum triglyceride value >3 mmol/l

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: CABG and intralipid infusion<br>Procedure: CABG surgery and subcutaneous cardiac monitor implantation Drug: Intralipid Lipid emulsion (Intralipid) for intravenous use, 1 ml/kg/day daily for 7 days post-surgery period (The first infusion beginning in operative period) | Drug: Intralipid<br>* Lipid emulsion (Intralipid) for intravenous use, 1 ml/kg/day daily for 7 days post-surgery period (The first infusion beginning in operative period)<br>|
| Active Comparator: CABG and omega-3 fatty acid infusion<br>Procedure: CABG surgery and subcutaneous cardiac monitor implantation Drug: Omegaven Lipid emulsion (omegaven) for intravenous use, 1 ml/kg/day daily for 7 days post-surgery period (The first infusion beginning in operative period) | Drug: Omega-3 fish oil emulsion (Omegaven)<br>* Lipid emulsion (omegaven) for intravenous use, 1 ml/kg/day daily for 7 days post-surgery period (The first infusion beginning in operative period)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom of Atrial Fibrillation or other atrial arrhythmias |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Omega-3 fatty acid, Ischemic Heart Disease, Atrial Fibrillation, Subcutaneous cardiac monitoring