Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000134527
Ethics application status
Approved
Date submitted
11/04/2006
Date registered
18/04/2006
Date last updated
22/02/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Dietary fish oil and post surgical atrial fibrillation
Scientific title
Use of n-3 polyunsaturated fatty acids to reduce post surgical atrial fibrillation: A prospective randomised study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial fibrillation post cardiac surgery 1102 0
Condition category
Condition code
Cardiovascular 1181 1181 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dietary fish oil or high monounsaturated sunflower oil commencing 3 weeks prior to surgery. If surgery is postponed after commencing the intervention, then treatment will continue until surgery. There is no maximum period of the intervention. the dose is 15 ml/day and is supplied as bulk liquid in 500 ml bottles. subjects are instructed to take the oil on juice
Intervention code [1] 983 0
None
Comparator / control treatment
high monounsaturated sunflower oil
Control group
Placebo

Outcomes
Primary outcome [1] 1594 0
Incidence of atrial fibrillation
Timepoint [1] 1594 0
first 6 post-operative days
Secondary outcome [1] 2886 0
• AF/AFL characteristics (incl. number of episodes, time to onset of first episode, mean and median duration of each episode, duration of longest episode, mean ventricular response rate during each episode of AF)
• AF burden (total time in AF)
• Mean heart rate
• Atrial premature beat frequency
Timepoint [1] 2886 0
Effect of n-3 fatty acids during the first 6 post-operative days.
Secondary outcome [2] 2887 0
• Post-operative complications including mortality
• Length of stay (ICU and total)
• Proportion of patients discharged within 6 post-operative days.
Timepoint [2] 2887 0
Effect of n-3 fatty acids throughout admission period.
Secondary outcome [3] 2888 0
• Association between hsCRP and atrial fibrillation.
Timepoint [3] 2888 0
Effect of n-3 fatty acids on hsCRP levels both prior to surgery and on post-operative day 1.
Secondary outcome [4] 2889 0
• Association between HRV and post-surgical AF/AFL
Timepoint [4] 2889 0
Effect of n-3 fatty acids onheart rate variability both prior to surgery and on day 4 post surgery.
Secondary outcome [5] 2890 0
Effect of n-3 fatty acids on measures of cardiac repolarisation and conduction
Timepoint [5] 2890 0
Both prior to surgery and on post-operative day 5.
Secondary outcome [6] 2891 0
Effect of n-3 fatty acids on adverse cardiac outcomes
Timepoint [6] 2891 0
At 6 months

Eligibility
Key inclusion criteria
Elective coronary bypass surgery (CABG and/or valve repair/replacement surgery)• Informed consent
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Prior documented AF/AFL• Current anti-arrhythmic drug therapy or amiodarone use within the previous 3 months• NYHA class IV heart failure• MI < 2 weeks• Any condition which may affect the ability to ingest or absorb dietary fat (e.g. known active oesophagitis, gastric or duodenal ulceration, inflammatory bowel disease, coeliac disease, chronic pancreatitis, chronic liver disease, recent abdominal radiation therapy)• use of dietary supplements rich in n-6 or n-3 oils, e.g. fish oil, flaxseed oil, evening primrose oil• habitually consume > one fish meal / week.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random sequence generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
subjects, physicians, nurses, assessor and data analyst are blinded to treatment allocation. To enhance masking of the different oils, citrus flavouring has been added to both oils, although subjects allocated to fish oil may be able to tell. The bulk oil on juice method of consumption minimises the occurrence of "fishy" burps usually encountered with capsules.
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
11/04/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 202 0
5000

Funding & Sponsors
Funding source category [1] 1292 0
Government body
Name [1] 1292 0
NHMRC
Country [1] 1292 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
North Tce, Adelaide, SA 5000
Country
Australia
Secondary sponsor category [1] 1142 0
None
Name [1] 1142 0
nil
Address [1] 1142 0
Country [1] 1142 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2623 0
Royal Adelaide Hospital
Ethics committee address [1] 2623 0
Ethics committee country [1] 2623 0
Australia
Date submitted for ethics approval [1] 2623 0
Approval date [1] 2623 0
22/12/2005
Ethics approval number [1] 2623 0
051209

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36250 0
Address 36250 0
Country 36250 0
Phone 36250 0
Fax 36250 0
Email 36250 0
Contact person for public queries
Name 10172 0
Dr Robert Metcalf
Address 10172 0
Cardiovascular Research Centre,
Royal Adelaide Hospital,
North Tce,
Adelaide SA 5000
Country 10172 0
Australia
Phone 10172 0
+61 8 82225581
Fax 10172 0
+61 8 82225895
Email 10172 0
robert.metcalf@health.sa.gov.au
Contact person for scientific queries
Name 1100 0
Dr Robert Metcalf
Address 1100 0
Cardiovascular Research Centre,
Royal Adelaide Hospital,
North Tce,
Adelaide SA 5000
Country 1100 0
Australia
Phone 1100 0
+61 8 82225581
Fax 1100 0
+61 8 82225895
Email 1100 0
robert.metcalf@health.sa.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.