Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1070948
Study information
Scientific title
Prevention of post-operative atrial fibrillation: pathophysyological characterisation of a pharmacological intervention based on a novel model of non-hypoxic pre-conditioning
Acronym
POAF
Study hypothesis
The trial is designed to test the hypothesis that the previous reinforcement of the antioxidant defense system reduces the occurrence of post-operative atrial fibrillation (AF) in patients subjected to cardiac surgery with extracorporeal circulation.
Please note that as of 16/01/2013, the following changes were made to the record:
1. The anticipated start date for this trial was updated from 01/07/2007 to 07/01/2007
2. The anticipated end date for this trial was updated from 01/03/2010 to 31/12/2011
Ethics approval
Local Ethics Committees (University of Chile Clinical Hospital, Faculty of Medicine of the University of Chile and Health Ministry of the Chilean Government) approved on the 5th June 2008 (ref: 100)
Study design
Double blind placebo-controlled clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Post-operative atrial fibrillation
Intervention
Oral administration of:
1. Omega-3 polyunsaturated fatty acids: 1 g every 12 hours, beginning 7 days before surgery, until hospital discharge
2. Vitamin C: 500 mg every 12 hours, beginning 2 days before surgery, until hospital discharge
3. Vitamin E: 400 IU daily, beginning 2 days before surgery, until hospital discharge
Total duration of follow-up for all arms: 14 days
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Ocurrence of post-operative atrial fibrillation. Basal electrocardiogram for patients in sinus rhythm and electrocardiographic monitoring will be performed throughout the hospitalisation period, in order to detect the occurrence of atrial fibrillation.
Secondary outcome measures
1. Biochemical markers of oxidative stress, performed on blood samples withdrawn: 7 and 2 days before surgery, the day of surgery, 8 hours and 4 days after surgery
2. Atrial tissue will be obtained during surgery to be analysed
Overall trial start date
07/01/2007
Overall trial end date
31/12/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged between 30 - 80 years, either sex
2. Scheduled for elective coronary artery bypass graft, valve surgery, or mixed
3. In sinus rhythm
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
150
Participant exclusion criteria
1. Previous heart surgery
2. Pre-operative documented history of chronic or paroxysmal AF
3. Comorbidities such as congenital or cardiac re-operation
4. Advanced hepatic disease (cirrhosis)
5. Chronic renal failure (serum creatinine greater than 2.0 mg/dL)
Recruitment start date
07/01/2007
Recruitment end date
31/12/2011
Locations
Countries of recruitment
Chile
Trial participating centre
Independencia 1027
Santiago
70058
Chile
Sponsor information
Organisation
Fondo de Desarrollo Científico y Tecnológico (Chile)
Sponsor details
c/o Maria Elena Boisier
Bernarda Morin 551
Providencia
Santigo
7500832
Chile
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Fondo de Desarrollo Científico y Tecnológico (ref: FONDECYT Nº 1070948), Chilean Government (Chile)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23916928
Publication citations
-
Results
Rodrigo R, Korantzopoulos P, Cereceda M, Asenjo R, Zamorano J, Villalabeitia E, Baeza C, Aguayo R, Castillo R, Carrasco R, Gormaz JG, A randomized controlled trial to prevent post-operative atrial fibrillation by antioxidant reinforcement., J. Am. Coll. Cardiol., 2013, 62, 16, 1457-1465, doi: 10.1016/j.jacc.2013.07.014.