Bisoprolol Versus Corticosteroid and Bisoprolol Combination for Prophylaxis Against Atrial Fibrillation After on Pump Coronary Artery Bypass Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- HEART RATE
研究概览
简要总结
Background: Atrial fibrillation (AF) is the most common cardiac arrhythmia that occurs after on pump coronary artery bypass graft (CABG) surgery. It is associated with postoperative complications, including increased risk of stroke, prolonged hospital stay and increased costs.
Objectives: The aim of this study was to find reliable, effective, safe and well tolerated tools for the prevention of AF after on pump coronary artery bypass surgery.
Patients and methods: The study included 176 patients (age range 40 to 79 years) and scheduled for elective on pump CABG operations without concomitant procedures. The patients were divided randomly into two equal groups. Group (A) in which bisoprolol was used for prophylaxis against atrial fibrillation after surgery. Group (B) in which bisoprolol and hydrocortisone were used for prophylaxis against atrial fibrillation after surgery. For each patient, the following data were collected: gender, preoperative diseases, intraoperative cross clamp time, cardiopulmonary bypass time, and Lt internal mammary Artery usage, incidence of postoperative atrial fibrillation, death, myocardial infarction chest infection and C - reactive protein levels.
详细描述
The study was conducted at The Cardiothoracic surgery intensive care unit of Ain Shams University hospitals during a period of 6 months. The study protocol was approved by "research and ethics committee" of anesthesia and intensive care department, Ain Shams University. Informative consent was obtained from the patients before enrolling in the study.
176 Patients were registered in the study. Patients were randomly allocated by computer-generated random number list into two study groups of 88 patients each, with a range of age between 40 and 79 years old and were undergoing elective on pump CABG operations without concomitant procedures.
Group A:
Patients received bisoprolol 5mg per oral (P.O.) in the evening of the operation and then one dose (5 mg) every twenty four hours during the next two days.
Group B:
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)
盲法说明
BLINDED
入排标准
- 年龄范围
- 40 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •.176 Patients were registered in the study.
- •.Range of age between 40 and 79 years old .Undergoing elective on pump CABG operations without concomitant procedures.
排除标准
- •: Patients with preoperative rhythm abnormalities (sick sinus syndrome,
- •atrioventricular conduction abnormalities,
- •history of chronic or intermittent AF),
- •pretreatment with classes I and III antiarrhythmic agents,
- •receiving anti-hypertensive drugs except angiotensin convertor enzyme (ACE) inhibitors,
- •thyroid disease,
- •renal or liver disease,
- •peripheral arterial atherosclerotic disease,
- •thrombophlebitis,
- •uncontrolled diabetes mellitus,
- •systemic bacterial or mycotic infection,
- •active tuberculosis,
- •Cushing's syndrome,
- •peptic ulcer,
- •psychotic mental disorder,
- •Herpes Simplex keratitis
- •chronic obstructive pulmonary disease were not included in the study.
研究组 & 干预措施
BISOPROLOL
BISOPROLOL 5mg per oral (P.O.) in the evening of the operation and then one dose (5 mg) every twenty four hours during the next two days.
干预措施: Bisoprolol (Drug)
hydrocortisone
hydrocortisone 100 mg intravenously is given in the evening of the operation and then 100 mg every eight hours during the next two days.
干预措施: Bisoprolol (Drug)
结局指标
主要结局
HEART RATE
时间窗: two days
atrial fibrillation
次要结局
未报告次要终点
研究者
RAMY AHMED
lecturer
Ain Shams University