Prevention of Atrial Arrhythmias by Infusion of Magnesium Sulphate after Lung Resection for Cancer

ISRCTN	ISRCTN01500324
DOI	https://doi.org/10.1186/ISRCTN01500324
Secondary identifying numbers	N0054186615

Submission date: 28/09/2007
Registration date: 28/09/2007
Last edited: 02/08/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

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 N Chaudhuri
Scientific

Department of Thoracic Surgery
The Cardiothoracic Centre
Thomas Drive
Liverpool
L14 3PE
United Kingdom

Study information

Study design	Single-centre controlled and randomised clinical trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
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 objectives	We hypothesize that the prophylactic infusion of magnesium sulphate significantly reduces incidences of postoperative atrial fibrillation in patients undergoing thoracotomy, pneumonectomy and lobectomy. This is a single-centre, controlled and randomised clinical trial. Study patients will be recruited into the trial from participating surgeons waiting lists and those consenting for the trial will be included in the trial register. Atrial arrhythmias are common after pulmonary procedures with reported incidences ranging from 10% to 20% after lobectomy and up to 40% after pneumonectomy. To date only one randomised study published nearly a decade ago showed that postoperative atrial tachyarrhythmias, mainly atrial fibrillation could be significantly reduced when magnesium sulphate was administered. A general consensus is still lacking on the efficacy of magnesium sulphate as anti-arrhythmic drug for patients undergoing lung cancer operation. We plan to investigate in this by carrying out a randomised, parallel, blinded, controlled trial involving a total of 240 patients (n=120 per group).
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Cancer: Lung
Intervention	Patients will be randomly allocated in equal numbers to treatment with or without magnesium sulphate and followed-up during the in-hospital perioperative period.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Magnesium Sulphate
Primary outcome measure	Atrial fibrillation will be assessed using a standard 12-lead ECG measurement from the onset of the Q wave to the end of the S wave.
Secondary outcome measures	1. Myocardial Infarction will be defined by two of the following three criteria if present: Unequivocal ECG changes. Elevation of cardiac enzyme(s): 3 times upper limit of creatinine kinase CK/CKMB) and above twice the upper limit of normal or elevated troponin (T/I). Chest pain typical of ischaemia lasting for more than 20 minutes. 2. Respiratory complications as determined by the requirement for postoperative mechanical ventilation greater than 24 hours or reintubation for ventilatory support after the day of surgery; pneumonia - defined as fever eukocytosis, pulmonary infiltrate requiring antibiotic therapy; air leak from thoracostomy tubes for more than six days postoperatively; lobar collapse on postoperative chest radiograph; empyema and bronchopleural fistula. Sputum retention defined as failure to clear bronchial secretions that can result in: bronchial obstruction, atelectasis, lobar collapse, secondary pulmonary infection. 3. Renal Complications - postoperative rise in serum creatinine above 200µmol/litre or requirement of postoperative dialysis support in a patient with normal preoperative renal function was considered to be a renal complication. 4. Neurological complications - a postoperative new cerebrovascular accident or transient ischaemic attack was considered to be a neurological complication. 5. Pulmonary embolus defined as a blockage of an artery in the lungs by fat, air, tumor tissue, or blood clot. 6. Death is defined as all-cause mortality and the cause of death will have to be specified. In the analysis, all deaths during the study period will be compared between the two groups.
Overall study start date	01/09/2006
Completion date	01/09/2008

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	240
Key inclusion criteria	240 subjects will be recruited. The investigator will be responsible for screening all patients listed for lung surgery at the CTC. Evidence from Terzi et al [32], had demonstrated that incidences of AF occurred in 10.7% of patients on magnesium sulphate as compared with 26.7% of control patients. We predict that at 90% power (2-sided ¿=0.05), 240 patients allowing for drop outs, deaths etc) are required to detect at least a 16% reduction in incidences of AF. Inclusion Criteria: 1. Elective for non-cardiac thoracic operations for lung cancer (lobectomy and pneumonectomy) 2. Ability to provide informed consent
Key exclusion criteria	1. Patients not undergoing major lung resection (see above) 2. Impaired renal function, preoperative creatinine >200 mol/L 3. Myocardial infarction within the last 6 months 4. Urgent or emergency operations 5. Video assisted thoracic surgery 6. Currently on drugs with antiarrhythmic properties 7. Patients with a history of preoperative cardiac arrhythmias
Date of first enrolment	01/09/2006
Date of final enrolment	01/09/2008

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Department of Thoracic Surgery

Liverpool
L14 3PE
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

The Cardiothoracic Centre Liverpool NHS Trust (UK), NHS R&D Support Funding

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