Phase III Study of Preoperative Amiodarone for Prevention of Atrial Fibrillation After Lung Resection
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Incidence of Post-operative Atrial Fibrillation
研究概览
简要总结
Atrial fibrillation is a very common complication of pulmonary resection. Patients who develop atrial fibrillation require additional treatment and are more likely to stay in the hospital for longer period of time increasing the costs associated with the operation. We propose a randomized controlled trial to see if oral amiodarone given for one week before surgery can prevent atrial fibrillation after pulmonary resection. We plan to evaluate the incidence of atrial fibrillation in patients who received preoperative amiodarone and compare them to the incidence of atrial fibrillation in patients who did not received preoperative amiodarone.
详细描述
Atrial fibrillation is a very common complication of pulmonary resection. Patients who develop atrial fibrillation require additional treatment and are more likely to stay in the hospital for longer period of time increasing the costs associated with the operation.
We propose a study to see if oral amiodarone given for one week before surgery can prevent atrial fibrillation after pulmonary resection. We plan to evaluate the incidence of atrial fibrillation in patients who received preoperative amiodarone and compare them to the incidence of atrial fibrillation in patients who did not received preoperative amiodarone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Resectable lung nodule or mass
排除标准
- •Allergy to amiodarone
- •Currently taking amiodarone
- •Documented atrial fibrillation within past 12 months
- •Known pulmonary fibrosis
- •Known hepatic dysfunction
- •Thyroid disease
- •2nd or 3rd degree heart block
- •Severe SA node disease
- •Bradycardia-induced syncope
- •Pregnancy
研究组 & 干预措施
1 - Amiodarone
Perioperative amiodarone
干预措施: Amiodarone (Drug)
2 - Control
Control arm, standard care with no perioperative amiodarone
干预措施: Control arm, standard care (Other)
结局指标
主要结局
Incidence of Post-operative Atrial Fibrillation
时间窗: 30 days
Number of patients with post-operative atrial fibrillation
次要结局
- Length of Post-operative Hospital Stay(1 week on average)
研究者
Malcolm DeCamp
Principal Investigator
Beth Israel Deaconess Medical Center