Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0054186615
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Single-centre controlled and randomised clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
Magnesium Sulphate
Primary outcome measures
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 trial start date
01/09/2006
Overall trial end date
01/09/2008
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
240
Participant 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
Recruitment start date
01/09/2006
Recruitment end date
01/09/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Thoracic Surgery
Liverpool
L14 3PE
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
The Cardiothoracic Centre Liverpool NHS Trust (UK), NHS R&D Support Funding
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