The Effect of Posterior Pericardiotomy on the Incidence of Atrial Fibrillation After Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 420
- 试验地点
- 1
- 主要终点
- Number of participants that experience Postoperative Atrial Fibrillation (POAF)
研究概览
简要总结
The purpose of this study is to determine if preforming a posterior left pericardiotomy prevents atrial fibrillation after cardiac surgery.
详细描述
Post-operative atrial fibrillation (POAF) is a common complication of cardiac surgery which is observed in 30-40% of patients. POAF may cause stroke, systemic embolism or cardiac failure and Its detection mandates for additional treatment with variable combinations of drugs to control cardiac rate or rhythm, anticoagulation, and electrical cardioversion, with their side effects and complications. As a result, POAF prolongs hospital stay and increases the costs of hospitalization. Several strategies aimed at reducing the incidence of POAF have been investigated, including beta-blockers, amiodarone, and statins, with unsatisfactory results. Posterior left pericardiotomy has been associated with a reduction in the incidence of POAF in a few studies. However, these studies are flawed by methodological limitations in terms of sample size, inclusion/exclusion criteria, randomization procedure, and suboptimal electrocardiographic monitoring strategies. Moreover, posterior left pericardiotomy requires additional operative time and is associated with procedure-specific complications. As a result, current evidence on posterior pericardiectomy failed to translate into changes in clinical practice and the incidence of POAF remains high.
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
- Single (Participant)
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
- •all consecutive patients admitted to the department of cardiothoracic surgery of the NYPH-WCMC will be screened for enrollment.
排除标准
- •preoperative non-sinus rhythm
- •history of previous atrial arrhythmia of any type
- •reoperations
- •mitral or tricuspid valve disease
- •surgery of the descending thoracic or thoracoabdominal aorta
- •need for hypothermic circulatory arrest
- •off pump operation
- •urgent/emergent presentation
- •disease of the left pleura or previous left thoracotomy
- •chest deformity
结局指标
主要结局
Number of participants that experience Postoperative Atrial Fibrillation (POAF)
时间窗: During hospitalization, approximately 5 days
POAF occurrences are defined as any irregular heart rhythm, without detectable P-wave, that lasts more than 30 seconds.
次要结局
- Duration of Postoperative Atrial Fibrillation (POAF)(During hospitalization, approximately 5 days)
- Duration of Hospitalization(During hospitalization, up to 100 days after surgery)
