Condition category
Circulatory System
Date applied
12/08/2009
Date assigned
02/09/2009
Last edited
06/01/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ramon Rodrigo

ORCID ID

Contact details

Independencia 1027
Santiago
70058
Chile

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

http://www.fondecyt.cl/

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

  1. 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.

Additional files

Editorial Notes