Comparison of elective early direct current (DC) cardioversion vs oral amiodarone in the treatment for new post-operative atrial fibrillation in patients undergoing coronary artery bypass grafting (CABG): a prospective randomised controlled study

ISRCTN	ISRCTN69583185
DOI	https://doi.org/10.1186/ISRCTN69583185
Secondary identifying numbers	N0054123058

Submission date: 30/09/2004
Registration date: 30/09/2004
Last edited: 14/11/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr W Dihmis
Scientific

Department of Cardiac Surgery
The Cardiothoracic Centre
Liverpool NHS Trust
Thomas Drive
Liverpool
L14 3PE
United Kingdom

Phone	+44 (0)151 228 1616

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study objectives	Elective DC cardioversion is one of the modalities of treating new atrial fibrillation. The procedure is deemed relatively safe, and immediately effective in most instances. However, there have been few studies comparing the results of early elective DC cardioversion with the results of the use of anti-arrhythmic drugs only as primary modalities of treatment for this condition, and the implications this may have on the incidence of heamodynamic compromise, thrombo-embolic events and hospital stay. The results of this study will help us in making the choice about the safest, quickest and most appropriate modality of treatment for these patients, and this would have favourable implications on patient outcome and duration of hospital stay.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Cardiovascular: Atrial fibrillation (AF)
Intervention	First time CABG patients who develop atrial fibrillation in the post-operative period following discharge from intensive care will be randomly assigned to one of two groups. Group one will be administered oral amiodarone and group two will receive DC cardioversion in addition to oral amiodarone. Daily electrocardiogram (ECG) will document heart rhythm. A blinded independent researcher will interpret the ECG on the day of discharge.
Intervention type	Other
Primary outcome measure	Patient's cardiac rhythm at discharge
Secondary outcome measures	1. Duration between onset of atrial fibrillation and reversion to sinus rhythm 2. Duration of hospital stay 3. Patient's rhythm on outpatient follow-up at 6 weeks postoperatively
Overall study start date	08/05/2003
Completion date	01/05/2005

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	400
Key inclusion criteria	400 first time CABG patients who develop atrial fibrillation in the post-operative period following discharge from intensive care will be randomly assigned to one of two groups.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	08/05/2003
Date of final enrolment	01/05/2005

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Department of Cardiac Surgery

Liverpool
L14 3PE
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

The Cardiothoracic Centre Liverpool NHS Trust (UK)

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