Condition category
Circulatory System
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
05/12/2014
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

Mr M Kudovala

ORCID ID

Contact details

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

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

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

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

Publication citations

Additional files

Editorial Notes