A Prospective Randomized Trial Comparing the Posterior Pericardial Window Versus Retro-Cardiac Drain for the Prevention of Postoperative Atrial Fibrillation and Pericardial Complications Following CABG
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 122
- 主要终点
- Incidence of postoperative atrial fibrillation and pericardial complications
研究概览
简要总结
aims to compare the efficacy of the posterior pericardial window versus retro-cardiac drain in preventing postoperative atrial fibrillation and pericardial complications following CABG, while assessing their impact on hospital and ICU stay, pericardial effusions, re exploration for bleeding, post-operative blood transfusions, and mortality.
详细描述
Coronary artery bypass grafting (CABG) is a cornerstone in the management of advanced coronary artery disease, yet it carries a notable risk of postoperative complications. Among these, postoperative atrial fibrillation (POAF) is particularly common, affecting up to 40% of patients and contributing to increased morbidity, prolonged ICU and hospital stays, and elevated healthcare costs.
Pericardial effusion and tamponade are also frequent sequelae after CABG operation, often exacerbating the risk of POAF and necessitating re-intervention. Traditionally, retro-cardiac drains have been used to evacuate pericardial fluid, but their efficacy in preventing effusion-related complications is limited.
The posterior pericardial window (PPW) technique has emerged as a promising alternative, offering improved drainage and reduced incidence of POAF, early and late pericardial effusion, and tamponade. Studies have shown that PPW may also shorten ICU and hospital stays, reduce pleural effusion, and lower the need for revision surgery due to bleeding.
Despite encouraging data, randomized trials directly comparing PPW and retro-cardiac drains remain scarce. This study aims to fill that gap by evaluating the effectiveness of PPW versus retro-cardiac drain in preventing postoperative atrial fibrillation and pericardial complications following CABG, with secondary outcomes including pleural effusion, ICU/hospital stay duration, revision surgery, and mortality.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult patients (aged 18 and above) scheduled for elective, first-time coronary artery bypass grafting (CABG).
- •Patients with preserved left ventricular function (ejection fraction ≥ 35%).
- •Ability to provide informed consent and comply with follow-up protocols.
- •No prior history of atrial fibrillation or other significant arrhythmias.
排除标准
- •Patients undergoing combined cardiac procedures (e.g., valve repair or replacement).
- •Emergency CABG cases or re-operations.
- •Known bleeding disorders or ongoing anticoagulation therapy that cannot be paused.
- •Severe pericardial adhesions or anatomical abnormalities preventing safe creation of a posterior pericardial window.
- •Chronic pulmonary disease or pleural pathology that may interfere with drainage assessment.
- •Patients with active infections or systemic inflammatory conditions.
结局指标
主要结局
Incidence of postoperative atrial fibrillation and pericardial complications
时间窗: During hospitalization and up to 3 months after surgery
Postoperative atrial fibrillation will be detected by continuous ECG monitoring during hospitalization. Pericardial complications, including early and late pericardial effusion, cardiac tamponade, and pleural effusion, will be assessed using echocardiography. The outcome will be reported as the number and percentage of participants experiencing any of these events.
次要结局
- Postoperative clinical outcomes (ICU stay, hospital stay, revision surgery, and in-hospital mortality)(From surgery until hospital discharge (up to 30 days))
研究者
Ahmed Mohamed Saad Abdelhamid
Principal Investigator
Assiut University