A Prospective, Randomized Controlled Trial Evaluating the Effectiveness of Posterior Pericardiotomy in Preventing Postoperative Atrial Fibrillation Among Yemeni Cardiac Surgical Patients
概览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Taiz University - Faculty of Medicine
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Number of participants with postoperative atrial fibrillation (POAF) until hospital discharge
概览
简要总结
A single-center, randomized controlled trial in Yemen evaluating whether posterior pericardiotomy (PP) reduces postoperative atrial fibrillation (POAF) after open-heart surgery. 210 patients undergoing CABG, aortic valve replacement, ascending aortic surgery, or combined procedures were randomized 1:1 to receive either posterior pericardiotomy (PP group, n = 106) or standard care (control group, n = 104). Outcomes assessed included POAF incidence, pericardial effusion, cardiac tamponade, ICU stay, mechanical ventilation, in-hospital mortality, and re-exploration for bleeding or tamponade.
详细描述
This single-center, prospective randomized controlled trial was conducted at the Cardiovascular and Kidney Transplantation Centre, Taiz University, Yemen. Adult patients undergoing elective open-heart surgery were randomized to receive either posterior pericardiotomy or standard care. The intervention involved creating a longitudinal posterior pericardiotomy incision parallel to the left phrenic nerve to facilitate pericardial drainage into the left pleural cavity.
The study evaluated the impact of posterior pericardiotomy on postoperative atrial fibrillation and related complications, including pericardial effusion and cardiac tamponade, compared with standard surgical management. Participants were monitored during hospitalization and followed for 30 days after surgery to assess clinical outcomes, resource utilization, and mortality.
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 (Outcomes Assessor)
盲法说明
Outcome assessors were blinded to the treatment group; participants and care providers were aware of the intervention.
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
- •Age ≥18 years.
- •Elective open-heart surgery:
- •Coronary artery bypass grafting (CABG) Aortic valve replacement Ascending aortic surgery Combined procedures (e.g., CABG + valve replacement)
排除标准
- •Previous cardiac or thoracic surgery
- •Left-sided pleural adhesions
- •Preoperative atrial fibrillation or other rhythm disorders
- •Hyperthyroidism
- •Renal failure with plasma creatinine \>2.0 mg/dL
- •Off-pump CABG
- •Mitral or tricuspid valve surgery (excluded due to distinct pathophysiology and POAF risk)
- •Refusal to participate
结局指标
主要结局
Number of participants with postoperative atrial fibrillation (POAF) until hospital discharge
时间窗: During hospitalization, approximately 5-7 days
Occurrence of atrial fibrillation documented by 12-lead ECG or continuous telemetry monitoring, lasting \>30 seconds, and occurring after cardiac surgery in patients with no prior history of atrial fibrillation.
次要结局
- Number of participants requiring postoperative antiarrhythmic medications(From surgery until hospital discharge (average 7-10 days))
- Number of Participants Requiring Systemic Anticoagulation or Cardioversion for Arrhythmia(From surgery until hospital discharge (average 7-10 days))
- Number of participants with cardiac tamponade requiring intervention(From date of surgery through 30 days postoperatively)
- Number of participants requiring surgical re-exploration for bleeding or tamponade(From date of surgery through 30 days postoperatively)
- Duration of Mechanical Ventilation (Hours)(From end of surgery until successful extubation (up to 72 hours postoperatively))
- Duration of ICU stay (hours)(From ICU admission after surgery until transfer to ward (average of 1-4 days))
- Duration of total hospital stay (days)(From date of surgery until hospital discharge (average of 7-10 days))
- Number of participants with in-hospital mortality (any cause)(From date of surgery until hospital discharge (average of 7-10 days))
- Number of participants experiencing major adverse cardiovascular events (MACE: stroke, myocardial infarction, or death)(From date of surgery through 30 days postoperatively)