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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Cardiac and respiratory complications following oesophagectomy, lobectomy or pneumonectomy
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One lung ventilation is an anaesthetic technique used in common surgeries like oesophagectomy, lobectomy and pneumonectomy and is associated with pulmonary (lung) complications including acute respiratory distress syndrome (ARDS) and cardiac (heart) complications after surgery. Heart and lung complications account for up to 50% of complications requiring admissions to Intensive Care Units (ICUs). The risk of dying is significantly increased in these patients when compared to patients who do not suffer these complications. There is also a long-term impact as these patients have physical and mental health issues. There is also a reduced rate of return to employment and an increase in healthcare costs, as the ICU is an expensive and limited resource and a bed in ICU costs up to ÂŁ1500. These patients also have a higher rate of healthcare contacts after discharge. Simvastatin belongs to a group of medications that are used to reduce fat levels in the blood. Simvastatin has also been shown to reduce inflammation and cell damage. In various studies it has been shown to reduce the rates of progression of severe infection, death from sepsis, and ICU admissions. In a small study simvastatin was found to reduce inflammation in the lungs and reduce the rates of heart, lung and infective complications. Development of these complications is associated with a significantly worse outcome including increased mortality (death rate), readmission to ICU, and increased ICU and hospital stay. The aim of this study is to find out whether treatment with simvastatin for four days before surgery and up to 7 days after surgery prevents cardiac and respiratory complications in patients undergoing elective oesophagectomy, lobectomy or pneumonectomy.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/305635552025 Results article in https://pubmed.ncbi.nlm.nih.gov/40633931/ (added 10/07/2025)
You can take part if:
Current inclusion criteria as of 23/06/2017:
1. Adult patients ≥18 years of age undergoing elective oesophagectomy, lobectomy or pneumonectomy
2. Female subjects must be surgically sterile, or be postmenopausal, or must agree to use effective contraception during the period of the trial and for at least 30 days after completion of treatment. A pregnancy test measured by urine HCG in females with child-bearing potential will be performed at pre-operative assessment cl
You may not be able to take part if:
1. Age <18 years2. Creatinine Kinase (CK) >5 times upper limit normal range in the local laboratory3. Known active liver disease (Child’s Pugh score > 11) or abnormal liver function tests i.e. transaminases (AST or ALT) >3 times upper limit normal range in the local laboratory4. Renal impairment (calculated creatinine clearance less than 30mL/minute)5. Inability to take oral medication pre-operatively6. Subject reported lactose intolerance7. Participation in other intervention trials within 30 days8. Current treatment with statins9. Known hypersensitivity to the study medication10. Previous adverse reaction to statins11. Concomitant use of fibrates or other lipid-lowering therapy12. Concomitant use of itraconazole, ketoconazole, posaconazole, voriconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, boceprivir, telaprevir, nefazodone, cyclosporine, danazol, amiodarone, amlodipine, verapamil or diltiazem, fusidic acid13. Patients must be able to understand and give signed and dated informed consent indicating that they understand all the pertinent aspects of the trial
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Dr
Murali
Shyamsundar
+44 (0)289 063 9572
murali.shyamsundar@qub.ac.uk
The study is sponsored by Belfast Health and Social Care Trust and funded by Health & Social Care Services R&D Award.
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You can print or share the study information with your GP/healthcare provider or contact the research team directly.
