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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01175330
Other study ID # FAFPAF-042
Secondary ID MCAFS-042
Status Terminated
Phase Phase 3
First received August 3, 2010
Last updated March 23, 2015
Start date August 2010
Est. completion date August 2013

Study information

Verified date March 2015
Source Meshalkin Research Institute of Pathology of Circulation
Contact n/a
Is FDA regulated No
Health authority Russia: Ethics Committee
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Terminated
Enrollment 39
Est. completion date August 2013
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Drug:
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)

Locations

Country Name City State
Russian Federation State Research Institute of Circulation Patholody Novosibirsk

Sponsors (1)

Lead Sponsor Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

References & Publications (1)

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 c — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Freedom of Atrial Fibrillation or other atrial arrhythmias 2 years Yes
Secondary All cause mortality 3 years Yes
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