A Randomized, Double-Blind, Controlled Trial of Combined Amiodarone and N-Acetylcysteine Versus Amiodarone Plus Placebo for the Prevention of Atrial Fibrillation in High Risk Patients Undergoing Thoracic Surgery
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 184
- 试验地点
- 16
- 主要终点
- rate of sustained (lasting >30 seconds) or clinically significant post-operative atrial fibrillation (POAF)
研究概览
简要总结
This trial will be comparing the combination of amiodarone and NAC (n=122) to amiodarone alone and NAC matched placebo (n=122) to determine the rates with which sustained (lasting >30 seconds) or clinically significant POAF is reduced in high risk patients within 7 days after major thoracic surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥18 years old scheduled for elective thoracic surgery (segmentectomy, lobectomy or bi-lobectomy, pneumonectomy or esophagectomy) and meeting one of the four following risk criteria:
- •1. Female & BNP ≥ 25pg/ml (no age limit)
- •2. Male gender <75 & BNP ≥ 25pg/ml
- •3. Male- age ≥75 (No BNP limit)
- •4. History of prior AF
- •Patients in sinus rhythm.
- •Patients with stable respiratory status (no respiratory distress).
- •Patients capable of providing written, informed consent.
排除标准
- •Patients scheduled for extrapleural pneumonectomy.
- •Hemodynamically unstable patients (not in cardiogenic shock or having an acute MI).
- •Patients with 2nd or 3rd degree atrioventricular (AV) block.
- •Patients with hypersensitivity to amiodarone or NAC.
- •Patients already taking class Ic or III antiarrhythmic drugs.
- •Hepatic insufficiency (≤2 times the upper normal limit of transaminase levels).
- •Renal insufficiency (creatinine ≥2.0 mg/dl).
- •Known pregnancy.
研究组 & 干预措施
Amiodarone + Placebo
Amiodarone loading: 150 mg IV in PACU over one hour, then 1.0 gm/24h x 2 + NAC loading matching placebo; 50 mg/kg IV in PACU over one hour, then 50 mg/kg/24h x 2 NAC matched placebo continuously for 48 hours.
干预措施: Placebo (Drug)
Amiodarone + Placebo
Amiodarone loading: 150 mg IV in PACU over one hour, then 1.0 gm/24h x 2 + NAC loading matching placebo; 50 mg/kg IV in PACU over one hour, then 50 mg/kg/24h x 2 NAC matched placebo continuously for 48 hours.
干预措施: Amiodarone (Drug)
Amiodarone + N-Acetylcysteine
Amiodarone loading: 150 mg IV in PACU over one hour, then 1.0 gm/24h x 2 + NAC loading: 50 mg/kg IV in PACU over one hour, then 50 mg/kg/24h x 2 and then continuously for 48 hours.
干预措施: Amiodarone (Drug)
Amiodarone + N-Acetylcysteine
Amiodarone loading: 150 mg IV in PACU over one hour, then 1.0 gm/24h x 2 + NAC loading: 50 mg/kg IV in PACU over one hour, then 50 mg/kg/24h x 2 and then continuously for 48 hours.
干预措施: N-Acetylcysteine (Drug)
结局指标
主要结局
rate of sustained (lasting >30 seconds) or clinically significant post-operative atrial fibrillation (POAF)
时间窗: within 7 days since operation
Atrial arrhythmias will be considered and defined as atrial fibrillation/flutter (AF) lasting great than 30 seconds and/or sustained supraventricular tachycardia (SVT) that are detected by continuous telemetry or that are clinically significant, requiring intervention and documented by 12-lead ECG by the clinical staff.
次要结局
未报告次要终点