Comparing the effect of fish oil on the occurrence of atrial fibrillation with placebo (olive oil) after coronary artery bypass graft surgery in patients who are undergoing CABG surgery in the rajaei heart center in 2014, a randomized clinical trial
This study is a randomized clinical trial in 392 patients scheduled for CABG surgery who referred to heart surgery clinic. After entering the study, using a randomized block, patients randomly entered into control and trial groups. 2000mg fish oil daily was given to the patients, twice a day (1 gr fish oil capsules each meal), containing 200 mg DHA and 300 mg EPA to intervention group and 2000 mg olive oil twice a day to placebo group. Intervention will begin at least 5 day before surgery and will continue for at least a week after surgery. Demographic data and other variables studied will be collected entering the study and during the study. In the open heart surgery ICU the patients will be monitored 24 hours. If AF occurs, start time and time of occurrence will be recorded. If patients have palpitations, ECG will be taken and if AF rhythm exists, will be recorded. Variables will be analyzed separately in the trial and placebo groups and results will be reported based on the information obtained.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013070713886N1
Registration date:2014-08-30, 1393/06/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-08-30, 1393/06/08
Registrant information
Name
Ali Vasheghani Farahani
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2392 2189
Email address
avasheghani@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2014-08-23, 1393/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of fish oil on the occurrence of atrial fibrillation with placebo (olive oil) after coronary artery bypass graft surgery in patients who are undergoing CABG surgery in the rajaei heart center in 2014, a randomized clinical trial
Public title
Comparing the effect of fish oil on the occurrence of atrial fibrillation with placebo (olive oil) after coronary artery bypass graft surgery in patients who are undergoing CABG surgery in the rajaei heart center in 2013, a randomized clinical trial
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria :
All patients over 18 years old who are candidate for CABG surgery.
Exclusion criteria: previous diagnosis of AF or atrial flutter; use of anti arrhythmic drugs (class 1&3) over the last 3 months; emergency surgery; MI over the last 2 weeks; emergency reoperation; post operative pacemaker placement; CABG and valve surgery; any conditions that can be effective on the digestion or absorption of food fatty acids; withdrew patients from continuing to participate in the study.
Age
From 18 years old to 99 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
392
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehan University of Medical Sciences
Street address
Tehan University of Medical Sciences,Taleghani st., Ghods st., Enghelab square, Tehran
City
Tehran
Postal code
1417653761
Approval date
2014-03-01, 1392/12/10
Ethics committee reference number
105180
Health conditions studied
1
Description of health condition studied
Post coronary artery bypass graft surgery atrial fibrilation.
ICD-10 code
I48
ICD-10 code description
Atrial fibrillation and flutter
Primary outcomes
1
Description
Atrial fibrilation
Timepoint
After coronary artery baypass graft surgery AF
Method of measurement
Checking of patients rhythm in open heart surgery ICU
Secondary outcomes
1
Description
Length of hospitalization
Timepoint
Time of discharge
Method of measurement
Patients records
Intervention groups
1
Description
Intervention group: 1 gr fish oil pearls containing 300mg EPA and 200 mg DHA, twice a day , given the patients at least 5 day before surgery until time of discharge.
Category
Treatment - Drugs
2
Description
Control group: 1 gr olive oil pearls , twice a day, given to the patients, at least 5 days before surgery until time of discharge.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Rajaie Heart center
Full name of responsible person
Dr. Ali Vasheghani Farahani
Street address
Rajaie Heart center, Vali Asr st., Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehan University of Medical Sciences
Full name of responsible person
Hajar Moammaie
Street address
Tehan University of Medical Sciences,Taleghani st., Ghods st., Enghelab square, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehan University of Medical Sciences
Full name of responsible person
Awat Yousefi Azar
Position
Msc in critical care nursing
Other areas of specialty/work
Street address
No 2, Derakhti alley, Nazari alley, South Madani st.
City
Tehran
Postal code
Phone
Fax
Email
a.youa@yahoo.com; aya.intensivist@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehan University of Medical Sciences
Full name of responsible person
Ali Vasheghani Farahani
Position
Fellowship of electrophysiology
Other areas of specialty/work
Street address
Tehran Heart Center, North Karegar st., Tehran
City
Tehran
Postal code
Phone
Fax
Email
avasheghani@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehan University of Medical Sciences
Full name of responsible person
Awat Yousefi Azar
Position
Msc in critical care nursing
Other areas of specialty/work
Street address
No 2, Derakhti alley, Nazari alley, South Madani st.
City
Tehran
Postal code
Phone
Fax
Email
a.youa@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)