Double-Blind Study of Atorvastatin Versus Placebo to Reduce Cardiopulmonary Complications After Thoracic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- Determine the Postoperative Complications Found in Each Group
研究概览
简要总结
This study will compare atorvastatin (Lipitor) with a placebo (inactive pill) to see if this drug reduces heart rhythm abnormalities (arrhythmias) or lung inflammation after thoracic surgery. Preliminary results suggest that cholesterol lowering drugs (statins) may reduce problems after surgery such as arrhythmias or lung inflammation which may be serious. This study will be randomized and double blind, meaning that patients are placed in groups purely by chance, like flipping a coin. Neither the patient or doctor will know which group the patient is in.
详细描述
Hypothesis
Statins attenuate perioperative inflammatory and oxidative mechanisms that contribute to the initiation and severity of cardiopulmonary complications after thoracic surgery.
Aim 1. To determine whether prophylactic administration of atorvastatin attenuates the inflammatory and oxidative response to surgery and significantly reduces the composite risk of cardiovascular morbidity (atrial fibrillation (AF), acute coronary syndrome, myocardial infarction (MI), cerebrovascular accident (CVA), pulmonary embolism) and mortality within 30 days after thoracic surgery.
Aim 2. To explore whether prophylactic administration of atorvastatin attenuates the inflammatory and oxidative (CRP, IL-6, TNF, and MPO) response to surgery and significantly reduces the overall risk of pulmonary complications (atelectasis, pneumonia, pneumonitis, acute respiratory failure) after thoracic surgery.
Aim 3. To explore the association of single nucleotide polymorphism (SNP) changes in genes linked to atrial fibrillation and inflammatory markers and development of pulmonary morbidity after thoracic surgery.
Aim 4. To explore whether an imbalance between metalloproteinase (MMP)-1 and its inhibitor (TIMP) is associated with postoperative atrial fibrillation risk and/or development of pulmonary morbidity after thoracic surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients ≥ 18 yr. scheduled for anatomic lung resection (segmentectomy, lingulectomy, possible or definite lobectomy, bilobectomy, pneumonectomy or extrapleural pneumonectomy) with or without chest wall resection or limited resection
- •Patients with regular cardiac rhythm
- •Patients able to take oral capsules
- •Patients capable of providing written, informed consent
- •Patients without known hepatic or kidney disease
排除标准
- •Patients already taking any statin, gemfibrozil (Lopid), or ezetimibe (Zetia)
- •Hypersensitivity to atorvastatin
- •Chronic atrial fibrillation
- •Patients already taking class Ic or III antiarrhythmic drugs
- •Known pregnancy a urine pregnancy test will be given to women of childbearing age
- •Known history of active hepatic disease or known hepatic insufficiency
- •Known history of active kidney disease or insufficiency
研究组 & 干预措施
1
Atorvastatin
干预措施: Atorvastatin (Drug)
2
placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Determine the Postoperative Complications Found in Each Group
时间窗: one week (minimum of 5 days) before surgery and continued for one week (minimum of 5 days) after surgery
To determine whether one week of preventive therapy with atorvastatin prior to surgery and one week after surgery reduced the composite rate of cardiovascular morbidity when compared to placebo.
次要结局
未报告次要终点