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Prevention of Post-Operative Atrial Fibrillation
ISRCTN ISRCTN45347268
DOI 10.1186/ISRCTN45347268
ClinicalTrials.gov identifier
EudraCT number
Public title Prevention of Post-Operative Atrial Fibrillation
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
Serial number at source 1070948
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
Lay summary Not provided at time of registration
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
Countries of recruitment Chile
Disease/condition/study domain Post-operative atrial fibrillation
Participants - 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
Participants - 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)
Anticipated start date 07/01/2007
Anticipated end date 31/12/2011
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 150
Interventions 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
Primary outcome measure(s) 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 measure(s) 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
Sources of funding Fondo de Desarrollo Científico y Tecnológico (ref: FONDECYT Nº 1070948), Chilean Government (Chile)
Trial website
Publications 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23916928
Contact name Dr  Ramon  Rodrigo
  Address Independencia 1027
  City/town Santiago
  Zip/Postcode 70058
  Country Chile
Sponsor Fondo de Desarrollo Científico y Tecnológico (Chile)
  Address c/o Maria Elena Boisier
Bernarda Morin 551
Providencia
  City/town Santigo
  Zip/Postcode 7500832
  Country Chile
  Sponsor website: http://www.fondecyt.cl/
Date applied 12/08/2009
Last edited 06/01/2014
Date ISRCTN assigned 02/09/2009
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