Prevention of Post-Operative Atrial Fibrillation
| ISRCTN | ISRCTN45347268 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45347268 |
| Secondary identifying numbers | 1070948 |
- Submission date
- 12/08/2009
- Registration date
- 02/09/2009
- Last edited
- 06/01/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Ramon Rodrigo
Scientific
Scientific
Independencia 1027
Santiago
70058
Chile
Study information
| Study design | Double blind placebo-controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Prevention of post-operative atrial fibrillation: pathophysyological characterisation of a pharmacological intervention based on a novel model of non-hypoxic pre-conditioning |
| Study acronym | POAF |
| Study objectives | 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(s) | 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) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 07/01/2007 |
| Completion date | 31/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 150 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 07/01/2007 |
| Date of final enrolment | 31/12/2011 |
Locations
Countries of recruitment
- Chile
Study participating centre
Independencia 1027
Santiago
70058
Chile
70058
Chile
Sponsor information
Fondo de Desarrollo Científico y Tecnológico (Chile)
Government
Government
c/o Maria Elena Boisier
Bernarda Morin 551
Providencia
Santigo
7500832
Chile
| Website | http://www.fondecyt.cl/ |
|---|---|
"ROR" |
https://ror.org/02ap3w078 |
Funders
Funder type
Government
Fondo de Desarrollo Científico y Tecnológico (ref: FONDECYT Nº 1070948), Chilean Government (Chile)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 15/10/2013 | Yes | No |
