Use of Corticosteroids on Prophylaxis of New-onset Arterial Fibrillation After Cardiac Surgery
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- overall occurrence of postoperative AF
研究概览
简要总结
Cardiopulmonary bypass and cardiac surgery are associated with a significant systemic inflammatory response that has been suggested playing a causative role in the development of postoperative atrial fibrillation (POAF). The goal of this study is to determine the efficacy of corticosteroids prophylaxis in preventing POAF, or length of intensive care unit (ICU) or hospital stay.
详细描述
Most cardiac operations are performed under cardiopulmonary bypass, however, it is well known that cardiopulmonary bypass often causes systemic inflammatory response characterized by leukocyte and high levels of C-reactive protein (CRP) complexes, as well high levels of inflammatory mediators that may contribute to postoperative complications including atrial fibrillation (AF), prolonged duration of intensive care unit (ICU) and hospital stay.
Postoperative atrial fibrillation has (POAF) been reported in 20% to 50% of patients following coronary artery bypass grafting (CABG) and is even higher after combined CABG and valve surgery.
It may increase stroke rates, trigger hemodynamic instability with heart failure and increase risk of thromboembolic complications.
The relationship between inflammation and atrial fibrillation after cardiac surgery is further strengthened by studies that showed that corticosteroid (CS) prophylaxis can reduce the occurrence of atrial fibrillation after cardiac surgery.
Corticosteroids (CS) can reduce the risk of atrial fibrillation after cardiac surgery in adults and reduce length of intensive care unit (ICU) 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
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective first time CABG or combined with valvular surgery.
- •Use of b-adrenergic blockade.
- •Normal sinus rhythm.
排除标准
- •History of heart block
- •History of previous episodes of AF or flutter
- •History of peptic ulcer disease
- •Permanent pacemaker
- •Any documented or suspected supraventricular or ventricular arrhythmias
- •Renal insufficiency (serum creatinine >20 mg/dL)
- •Uncontrolled diabetes mellitus
- •Systemic bacterial or mycotic infection
- •Urgent or emergency surgery
- •Patient underwent cardiac surgery without using cardiopulmonary bypass
研究组 & 干预措施
Methylprednisolone (MP) group
42 patients, given 1 g of methylprednisolone post cardiopulmonary bypass immediately postoperative
干预措施: 1 g of methylprednisolone (divided into 250 mg every 6h started once the patient arrived the pos-toparative ICU) (Drug)
结局指标
主要结局
overall occurrence of postoperative AF
时间窗: during the first 72 hours after cardiac surgery
次要结局
- length of the hospital stay(From the day of the surgery until the date of discharge from the hospital, up to 30 days.)
- length of the ICU stay(from the day of the surgery ( postoperative ICU admission) until the time of transfer from the ICU to the surgical ward , up to 25 days.)
研究者
Eman mohamed hesham elshaer
lecturer of anesthesia
Ain Shams University