Condition category
Cancer
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
02/08/2012
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 N Chaudhuri

ORCID ID

Contact details

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

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

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

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

Publication citations

Additional files

Editorial Notes