| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN01500324 |
| Date ISRCTN assigned | 28/09/2007 |
| Local reference number(s) | N0054186615 |
| Public title | Prevention of Atrial Arrhythmias by Infusion of Magnesium Sulphate after Lung Resection for Cancer |
| Scientific title |
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| Acronym | N/A |
| Disease/condition/study domain | Cancer: Lung |
| 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. |
| Design/methodology | Single-centre, controlled and randomised clinical trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - 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. |
| Participants - exclusion criteria | Patients not undergoing major lung resection (see above). Impaired renal function, preoperative creatinine >200 mol/L. Myocardial infarction within the last 6 months. Urgent or emergency operations. Video assisted thoracic surgery. Currently on drugs with antiarrhythmic properties. Patients with a history of preoperative cardiac arrhythmias . |
| Patient information material |
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| Anticipated start date | 01/09/2006 |
| Anticipated end date | 01/09/2008 |
| Status of trial | Ongoing |
| Target number of participants | 240 |
| Interventions | 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, control trial involving a total of 240 patients (n=120 per group).
Patients will be randomly allocated in equal numbers to treatment with or without magnesium sulphate and followed-up during the in-hospital perioperative period. |
| Primary outcome measure(s) | 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 measure(s) | 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. |
| Sources of funding | The Cardiothoracic Centre Liverpool NHS Trust
NHS R&D Support Funding |
| Sponsor name | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Mr N Chaudhuri |
| Contact details | Department of Thoracic Surgery
The Cardiothoracic Centre
Thomas Drive
Liverpool
United Kingdom
L14 3PE |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN01500324 |
| Date last extracted from ISRCTN register | 17/04/2008 |
