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

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01175330

Enrollment

Registered

2010-08-04

Start date

2010-08-31

Completion date

2013-08-31

Last updated

2015-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Ischemic Heart Disease

Keywords

Omega-3 fatty acid, Ischemic Heart Disease, Atrial Fibrillation, Subcutaneous cardiac monitoring

Brief summary

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

Interventions

DRUGOmega-3 fish oil emulsion (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)

DRUGIntralipid

Lipid emulsion (Intralipid) for intravenous use, 1 ml/kg/day daily for 7 days post-surgery period (The first infusion beginning in operative period)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Freedom of Atrial Fibrillation or other atrial arrhythmias	2 years

Secondary

Measure	Time frame
All cause mortality	3 years

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026