Magnesium sulphate for the prevention of supra-ventricular dysrhythmia following non-cardiac thoracic surgery
| ISRCTN | ISRCTN22028180 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22028180 |
| EudraCT/CTIS number | 2004-002818-11 |
| Secondary identifying numbers | Version 5 |
- Submission date
- 11/06/2008
- Registration date
- 18/07/2008
- Last edited
- 22/08/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Roger Stedman
Scientific
Scientific
2nd Floor
Lincoln House
Heartlands Hospital
Bordesley Green East
Birmingham
B5 5SS
United Kingdom
Study information
| Study design | Single-centre prospective double-blind randomised placebo-controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study acronym | MAGNETS |
| Study objectives | The prophylactic perioperative correction of magnesium deficiency by infusion of magnesium sulphate to all patients presenting for thoracotomy or thoracolaparotomy for pneumonectomy, lobectomy or oesophagectomy will significantly reduce the incidence of supra-ventricular dysrhythmias post operatively. |
| Ethics approval(s) | South Birmingham Research Ethics Committee. Date of approval: 04/05/2005 (ref: 05/Q2707/1) |
| Health condition(s) or problem(s) studied | Supra-ventricular dysrhythmias in patients following non-cardiac thoracic surgery |
| Intervention | Patients are randomised into either the placebo or magnesium groups. Patients receive either placebo or 5 g magnesium sulphate infusion intra-operatively, day 1 and day 2 post-operatively. Continuous electrocardiogram (ECG) recording for 5 days will be commenced using a holter (non-invasive) recorder after induction of anaesthesia. ECG data will be analysed by a cardiac physiologist who is blinded from which treatment group the patient is in. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Magnesium sulphate |
| Primary outcome measure | To demonstrate a clinically and statistically significant reduction in the incidence of postoperative supra-ventricular dysrhythmias in the patient group who have received magnesium in comparison to the placebo group. It is aimed that patients have holter monitoring for 5 days post-operatively. |
| Secondary outcome measures | 1. Length of hospital stay 2. Thirty-day mortality |
| Overall study start date | 01/06/2006 |
| Completion date | 30/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 200 |
| Key inclusion criteria | 1. Both male and female patients 2. Above 18 years; no upper age limit 3. Patients presenting to the Department of Thoracic Surgery at Birmingham Heartlands Hospital for elective lobectomy, bi-lobectomy, pneumonectomy or oesophagectomy |
| Key exclusion criteria | 1. Evidence of renal failure (serum creatinine of >130) 2. Liver failure 3. Pre-existing cardiac arrhythmia 4. Undergoing long-term treatment for an arrhythmia 5. On long-term treatment with nifedipine or aminoglycosides 6. Known hypersensitivity to magnesium sulphate 7. If preoperative magnesium level is equal or greater than 1.2 mmol/l 8. If they are unwilling or unable to give informed consent for their participation or if they withdraw consent 9. Patients who have participated in another interventional study within the previous 3 months |
| Date of first enrolment | 01/06/2006 |
| Date of final enrolment | 30/06/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
2nd Floor
Birmingham
B5 5SS
United Kingdom
B5 5SS
United Kingdom
Sponsor information
Heart of England NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Research and Development Department
1st Floor
Lincoln House
Bordesley Green East
Birmingham
B5 5SS
England
United Kingdom
| Website | http://www.heartofengland.nhs.uk |
|---|
Funders
Funder type
Charity
British Heart Foundation (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- the_bhf, The British Heart Foundation, BHF
- Location
- United Kingdom
European Association of Cardiothoracic Anaesthesiologists (EACTA) (Ireland)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2011 | Yes | No |
