Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0054131771
Study information
Scientific title
Efficacy of magnesium and sotalol in prevention of Atrial fibrillation (AF) following cardiac surgery
Acronym
Study hypothesis
We aim to study the efficacy of this combination of sotalol and magnesium in more clinically common patient groups like patients undergoing valve surgery, impaired left ventricular (LV) function and borderline respiratory function which makes it more useful to our patient population and hence our practice. This study will be unique from previous studies in that it looks at more patients who are in-line with our day to day practice and also analyses the heretofore most efficient and least complicating change in cardiac surgery and ensure shorter hospital stay and better patient care. The economic implications of 25% of patients treated for atrial fibrillation and good proportion going on to have lifelong treatment with or without warfarin is quite obvious.
Ethics approval
Not provided at time of registration
Study design
Randomised double-blind controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Cardiovascular: Atrial fibrillation (AF)
Intervention
2 groups - a control group given placebo and a study group given sotalol with magnesium.
Preoperative assessment of electrocardiogram (ECG), serum potassium and magnesium levels. ECG repeated on postoperative days, 1, 2, 4, 7 and 6 weeks. QTc noted for the ECGs. Serum potassium and magnesium are measured every day for seven days. Drugs administered: Sotalol 80 mg twice daily started on first postoperative day and continued for five days and decreased to 40 mg twice daily for the next six weeks and then terminated. If the patients heart rate slows down to less than 50 beats per minute when on a 80 mg dose then the dose is decreased to 40 mg twice daily even if its earlier than five days. Magnesium 4 g intravenously first dose given when patient arrives in intensive therapy unit (ITU), second dose of 4 g is given post operatively 24:00 hrs on the night of procedure in the intensive care. This is followed by magnesium sulphate 4 g intravenously twice daily for the next two days.
Intervention type
Drug
Phase
Not Applicable
Drug names
Magnesium and sotalol
Primary outcome measures
1. To monitor the frequency of atrial fibrillation following pre-operative treatment with sotalol and magnesium and to determine its efficacy in a large group of cardiac surgery patients.
2. The prevention of Atrial Fibrillation in patients undergoing Cardiac Surgery
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/12/2003
Overall trial end date
01/05/2004
Reason abandoned
Eligibility
Participant inclusion criteria
Therapeutic research: All patients admitted for cardiac surgery in The Cardiothoracic centre are potential participants. All the details of the study are explained to the patients and a patient information sheet is given to them. Following this, a proper consent is obtained.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
98 patients per group needed to detect a reduction in AF rate to 10% at 90% power, therefore 200 patients (100 per group) will be recruited.
Participant exclusion criteria
1. Patients who are in another trial that might have a bearing or influence in outcome in this study
2. Patients undergoing aortic procedure, preoperative atrial fibrillation or second or third degree heart block and patients with preoperative creatinine value of more than 200.
Recruitment start date
01/12/2003
Recruitment end date
01/05/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Liverpool NHS Trust
Liverpool
L14 3PE
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
The Cardiothoracic Centre Liverpool NHS Trust (UK)
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