Omega 3 Fatty Acid Efficiency for Prevention of Atrial Fibrillation After Coronary Artery Bypass Grafting
NCT ID: NCT01175330
Last Updated: 2015-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
39 participants
INTERVENTIONAL
2010-08-31
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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CABG and intralipid infusion
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)
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)
CABG and omega-3 fatty acid infusion
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)
Omega-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)
Interventions
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Omega-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)
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)
Eligibility Criteria
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Inclusion Criteria
* Signed, documented informed consent prior to admission to the study.
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Meshalkin Research Institute of Pathology of Circulation
NETWORK
Responsible Party
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Efremov Sergey
Anesthesist
Locations
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State Research Institute of Circulation Patholody
Novosibirsk, , Russia
Countries
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References
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Lomivorotov VV, Efremov SM, Pokushalov EA, Romanov AB, Ponomarev DN, Cherniavsky AM, Shilova AN, Karaskov AM, Lomivorotov VN. Randomized trial of fish oil infusion to prevent atrial fibrillation after cardiac surgery: data from an implantable continuous cardiac monitor. J Cardiothorac Vasc Anesth. 2014 Oct;28(5):1278-84. doi: 10.1053/j.jvca.2014.02.019. Epub 2014 Jul 11.
Other Identifiers
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MCAFS-042
Identifier Type: -
Identifier Source: secondary_id
FAFPAF-042
Identifier Type: -
Identifier Source: org_study_id
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