Preoperative Oral Magnesium Versus Standard of Care to Prevent Postoperative Atrial Fibrillation Following Coronary Surgery (POMAF-CS): A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- postoperative atrial fibrillation
研究概览
简要总结
Post operative atrial fibrillation following coronary surgery (POAF) is a common complication that can affect 10-50% of patients.
Intravenous magnesium, administered per-or post-operatively, reduces the incidence of POAF. However, the effect of preoperative magnesium loading on the incidence of POAF is not yet studied.
200 patients admitted for elective coronary surgery under Cardiopulmonary bypass will be included in this prospective randomized controlled trial.
Treatment group will receive preoperative oral magnesium and control group will receive placebo for 3 days before the planned coronary artery surgery.
The occurrence of POAF will be studied as a main outcome.
详细描述
Post operative atrial fibrillation following coronary surgery (POAF) is a common complication that can affect 10-50% of patients. It is associated with many complications. POAF increases the postoperative length of stay and increases the cost of hospitalization.
Several studies and meta-analyzes have demonstrated the beneficial effect of intravenous magnesium (Mg), administered per-or post-operatively, in reducing the incidence of POAF. However, the effect of preoperative magnesium loading on the incidence of POAF is not yet studied.
The aim of this study is to study the effect of oral Mg, administered preoperatively, on the incidence of POAF.
Following IRB approval, 200 patients admitted for elective coronary surgery under Cardiopulmonary bypass will be included in this prospective randomized controlled trial. Patients will be allocated inn a 1: 1 ratio in 2 groups:
- Treatment group will receive preoperatively 8 tablets of Mg (3.2 g) per day, at day (-3), day (-2), and day (-1) before the day of planned coronary artery surgery.
- Control group will receive 8 tablets of placebo daily,at day (-3), day (-2), and day (-1) before the day of planned coronary artery surgery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
treatment concealment will be managed by the central pharmacy of the hospital, which will dispense treatment according to the randomization plan.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients
- •Coronary artery disease
- •Planned coronary artery surgery
- •signed informed consent
排除标准
- •Preoperative supraventricular dysrhythmia including atrial fibrillation, either acute or chronic
- •Left ventricular EF < 30%
- •Urgent surgery
- •Redo surgery
- •Permanent preoperative pacemaker
- •Preoperative anti arrythmia drugs classes I and III
- •Post operative inotrope drugs
- •Postoperative bradycardia necessitating electrosystolic pacing
- •Preoperative heart rate less than 50 bpm
- •documented preoperative dysthryroidism
- •2nd and 3rd degree atrioventricular bloc
- •Renal failure with GFR < 30 ml/min/1.73 m²
研究组 & 干预措施
Preoperative oral Magnesium
Magnesium sulfate 8 tablets (8 x 0.4 g) per day, PO, for the 3 days preceding the surgical intervention
干预措施: Magnesium Sulfate (Drug)
Control
Placebo oral tablet, for Magnesium Sulfate tablets, PO, for the 3 days preceding the surgical intervention
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
postoperative atrial fibrillation
时间窗: 7 postoperative days
New onset of atrial fibrillation clinically or telemetry detected and confirmed by EKG
次要结局
- Recurrence of atrial fibrillation(7 postoperative days)
- Ventricular response rate(During the atrial fibrillation episodes)
研究者
Samia Madi Jebara
Professor
St Joseph University, Beirut, Lebanon