Prevention by HMGCoA reductase inhibition of ALI associated with one lung ventilation following oesophagectomy by a Reduction of Pulmonary vascular dysfunction and inflammation (Prevention-HARP) - Acute lung injury post one lung ventilation; effects of simvastati
- Conditions
- Acute lung injury (ALI)
- Registration Number
- EUCTR2007-002454-37-GB
- Lead Sponsor
- The Royal Group Hospitals Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
Adult patients undergoing oesophagectomy for oesophageal cancer at the Royal Victoria Hospital, Belfast (RVH)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
•age < 18 years
•creatinine kinase (CK) > 5 times upper limit normal range
•known active liver disease (Child’s Pugh score > 11), or abnormal liver function tests: transaminases > 3 times upper limit normal range
•renal impairment (calculated creatinine clearance less than 30mL/minute)
•inability to take oral medication pre-operatively
•known lactose intolerance
•participation in other intervention trials within 30 days
•pregnancy, breast-feeding or women of childbearing potential not using adequate contraception;
•patients taking corticosteroids or non-steroidal anti-inflammatory drugs
•current treatment with statins
•known hypersensitivity to the study medication
•a previous adverse reaction to statins
•concomitant use of fibrates or other lipid-lowering therapy
•concomitant use of itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, nefazodone, grapefruit juice, cyclosporine, danazol, amiodarone, verapamil or diltiazem.
•consent declined
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method