Efficacy of magnesium and sotalol in prevention of Atrial fibrillation (AF) following cardiac surgery
| ISRCTN | ISRCTN85229111 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85229111 |
| Secondary identifying numbers | N0054131771 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 01/04/2020
- 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 M Kudovala
Scientific
Scientific
Department of Cardiac Surgery
The Cardiothoracic Centre
Liverpool NHS Trust
Thomas Drive
Liverpool
L14 3PE
United Kingdom
Study information
| Study design | Randomised double-blind controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Efficacy of magnesium and sotalol in prevention of Atrial fibrillation (AF) following cardiac surgery |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Magnesium and sotalol |
| Primary outcome measure | 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 study start date | 01/12/2003 |
| Completion date | 01/05/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | 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. |
| Key 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. |
| Key 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. |
| Date of first enrolment | 01/12/2003 |
| Date of final enrolment | 01/05/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Liverpool NHS Trust
Liverpool
L14 3PE
United Kingdom
L14 3PE
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Hospital/treatment centre
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 |
Editorial Notes
01/04/2020: No publications found, all search options exhausted, study status unverified.
