Primary Objectives
1 Determine the incidence of atrial fibrillation after lung resection (lobectomy or greater) in patients receiving (blinded) oral statins versus fish oil supplementation versus placebo.
The primary endpoint of the study is the new onset of sustained (15 min or >) or clinically significant (requiring intervention) atrial fibrillation (AF) or supraventricular tacharrhythmia (SVT) during the first 4 days after the operation. Definitions are based on the American College of Cardiology and American Heart Association Physician Consortium. AF is defined as replacement of consistent P waves with rapid oscillations or fibrillatory waves that vary in amplitude, shape, and timing, associated with irregular, frequently rapid ventricular response. SVT is defined as the new onset of paroxysmal supraventricular tachycardia or multifocal atrial tachycardia necessitating treatment. A treated arrhythmia is defined as any of the above arrhythmias that received specific targeted therapy by the surgical housestaff, the physician extenders, a consulting cardiologist, or the attending surgeon. Once any of these definitions have been met, the participant will be considered as positive for this endpoint.
2 Determine the hospital length of stay after lung resection (lobectomy or greater) in patients receiving (blinded) oral statins versus fish oil supplementation versus placebo.
Secondary Objectives
1 Determine the effect of prophylaxis on the incidence of associated morbidity: - Pulmonary (pneumonia, acute respiratory distress syndrome, need for ventilator support, duration of ventilatory support)
- Cardiac (myocardial infarct, ventricular arrhythmias, hypotension, bradycardia).
- Hepatic: SGOT and SGPT will be obtained on days 1 and 3 postoperatively, and on day 8 or on day of discharge, whichever comes first. If either SGOT or SGPT are > 2.5 x ULN study drug will be discontinued.
- Allergic reactions: The first dose of the study drug will be taken in the presence of the research nurse. The research nurse will observe the patient for 30 minutes and document any evidence of allergic reactions (swelling, shortness of breath, wheezing, hypotension, rash) and any other new signs or symptoms. In addition, the patient will be given a diary to record any symptoms while taking the medication at home.
- Respiratory infection is defined using the American and European Consensus Conference definition. Patients must have 3 of the following signs and symptoms to be characterized as having a respiratory infection: 1) WBC >11,500 or <5,000; 2) persistent infiltrate on chest xray for >48 hours; 3) temperature of 101.5 degrees Fahrenheit or greater, or 96 degrees Fahrenheit or less; 4) purulent sputum on a gram stain; 5) growth of pathogenic bacteria on sputum culture. Alternatively, a respiratory infection will be defined as any patient who receives targeted therapy to treat a respiratory infection by the attending surgeon.
2 Determine the effect of prophylaxis on mortality.
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