Pragmatic Amiodarone Trial to Reduce Postoperative Atrial Fibrillation in Patients Undergoing Cardiac Surgery
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 242
- 主要终点
- Postoperative atrial fibrillation
研究概览
简要总结
Postoperative atrial fibrillation is quite common after cardiac surgery with up to 1 in 3 patients experiencing this abnormal heart rhythm. Amiodarone, a medication commonly used to treat atrial fibrillation, has been previously shown to be an effective prophylactic agent at decreasing the occurrence of postoperative atrial fibrillation in patients who underwent coronary artery bypass surgery. However, despite many studies which have demonstrated its effectiveness, it has not been widely used due to the concern of side effects that can occur such as slow heart rate, low blood pressure, and lung toxicity. We have designed a study to test the effectiveness and safety of a short course of postoperative prophylactic amiodarone for patients undergoing non-coronary artery bypass cardiac surgery. We hypothesize that patients who receive the prophylactic amiodarone will have decreased rates of postoperative atrial fibrillation without significantly increased side effects compared to patients who receive the standard postoperative care after non-coronary artery bypass cardiac surgery.
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
- •>= 18 years of age
- •All genders
- •All non-coronary artery bypass cardiac surgery patients
- •Preoperative normal sinus rhythm
排除标准
- •Pre-existing atrial fibrillation or atrial arrhythmias
- •Pre-existing heart block
- •Cardiogenic shock
- •Sick sinus syndrome
- •Marked sinus bradycardia
- •Preoperative amiodarone use
- •Contraindication to amiodarone use
- •PR interval > 240 ms
- •QTc > 550 ms
- •2nd or 3rd degree heart block
- •Liver impairment (INR > 1.7, AST/ALT > 2x normal)
- •Uncontrolled hyperthyroidism or hypothyroidism
- •Interstitial lung disease
- •Pregnancy and/or breastfeeding
- •Known hypersensitivity to any components of amiodarone, including iodine
- •Emergent operation
- •Planned MAZE or Pulmonary Vein Isolation procedure
研究组 & 干预措施
Standard of Care Arm
Patients randomized to the Standard of Care Arm will receive the regular care provided to cardiac surgery patients.
Amiodarone Arm
In addition to the regular care provided to cardiac surgery patients, those in the Amiodarone Arm will also receive the amiodarone regimen.
干预措施: Amiodarone (Drug)
结局指标
主要结局
Postoperative atrial fibrillation
时间窗: At least 1 minute duration, occurring before or on postoperative day 7
The occurrence of postoperative atrial fibrillation detected by continuous telemetry, 12-lead electrocardiogram, and/or continuous ambulatory monitoring device through postoperative day 7.
次要结局
- Stroke(Either in-hospital or within 30 days of procedure)
- Operative mortality(Either in-hospital or within 30 days of procedure)
- Postoperative hospital length of stay(Up to 90 days)
- Readmission(Within 30 days of procedure)
- Myocardial infarction(Either in-hospital or within 30 days of procedure)
- Persistence of atrial fibrillation at discharge(Up to 90 days)
- Transient ischemic attack(Either in-hospital or within 30 days of procedure)
- Electrical cardioversion(Either in-hospital or within 30 days of procedure)
- Hemodynamic instability(Either in-hospital or within 30 days of procedure)
- Initiation of systemic anticoagulation(Either in-hospital or within 30 days of procedure)
- Symptomatic bradycardia(Either in-hospital or within 30 days of procedure)
- Number of patients with Amiodarone-related pulmonary toxicity(Either in-hospital or within 30 days of procedure)
研究者
Asishana A Osho
Assistant Professor of Surgery
Massachusetts General Hospital