Effect of Left Posterior Pericardiotomy for the Prevention of Postoperative Atrial Fibrillation in Coronary Artery Bypass Grafting: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 270
- 试验地点
- 2
- 主要终点
- occurence rate of postoperative atrial fibrillation
研究概览
简要总结
This study is planned to evaluate the effect of left posterior pericardiotomy for the prevention of postoperative atrial fibrillation after coronary artery bypass grafting. Eligible patients will be randomized to be created or not to be created the left posterior pericardiotomy at the end of the operation, and the incidence of postoperative atrial fibrillation will be compared.
详细描述
Postoperative atrial fibrillation (POAF) is a common complication after cardiac surgery, particularly after coronary artery bypass grafting (CABG), and is associated with prolonged in-hospital stay and increased adverse outcomes, including death and stroke. There is evidence that pericardial effusion can trigger the occurence of POAF. Therefore, this study is aimed to evaluate the effect of left posterior pericardiotomy for the prevention of POAF after CABG.
Patients who are planned to undergo off-pump CABG will be randomized to be created or not to be created the left posterior pericardiotomy at the end of the operation, and the incidence of postoperative atrial fibrillation will be compared as the primary outcome. Secondary outcomes will include early clinical outcomes and hospital stay.
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
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who are planned to undergo coronary artery bypass grafting
- •patients aged ≥19 years
排除标准
- •patients who are planned to undergo other concomitant cardiac procedures (e.g. valve procedures, aorta procedures)
- •patients who undergo coronary artery bypass grafting using cardiopulmonary bypass
- •patients who are documented with paroxysmal, persistent, or permanent atrial fibrillation before operation
- •patients who have a history of cardiac surgery
- •patients who have a history of pericardial disease
- •patients who have severe adhesion at left pleural cavity which precludes effective left posterior pericardiostomy
- •patients who refuse to participate in this study
研究组 & 干预措施
Pericardiostomy
The patients who were created with left posterior pericardiotomy during the operation
干预措施: left posterior pericardiostomy (Procedure)
No pericardiostomy
The patients who were not created with left posterior pericardiotomy during the operation
结局指标
主要结局
occurence rate of postoperative atrial fibrillation
时间窗: From date of operation until postoperative day 7
any short run of atrial fibrillation which occurred during postoperative period before discharge
次要结局
- operative mortality(at 30 days)
研究者
Ho Young Hwang
Professor
Seoul National University Hospital