Evaluation of the Role of Magnesium in Prevention of AF Post Cardiac Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Number of Participants With New Episodes of Atrial Fibrillation
研究概览
简要总结
Atrial fibrillation (AF) is a common complication after cardiac surgery. Most studies suggest that the frequency ranges between 25-40%.
Some studies have shown that serum hypomagnesaemia is common after coronary artery bypass grafts (CABG) and other types of cardiac surgery and is associated with postoperative morbidity such as atrial tachyarrhythmia.
The aim of the present study is to investigate the anti-arrhythmic effect of Magnesium Sulfate in prevention of atrial fibrillation post cardiac surgery.
详细描述
Atrial fibrillation (AF) is a common complication after cardiac surgery. Most studies suggest that the frequency ranges between 25-40%.
Several reports have indicated that postoperative AF is associated with an increased length of in-hospital stay (LOS) and consequently a greater utilization of health care resources.
Postoperative AF is also associated with higher rates of postoperative stroke, compromised cardiac function, and adverse effects from drugs used to prevent AF.
Despite many years of clinical experience and a large amount of investigation, prevention, and treatment of postoperative AF remain controversial. Many questions about the mechanisms and pathophysiology of AF remain unanswered, further contributing to the ambiguity in reaching consensus about appropriate treatment. Increasing patient age, valvular lesion and dilated atrial diameter is generally considered the greatest risk factor for postoperative AF and an aging population suggest that postoperative AF will continue to be a considerable problem in the future.
Magnesium (Mg) is an important intracellular ion with electrophysiological properties. It is essential for optimal metabolic cell function. Mg has proven effective for treating eclampsia, preeclampsia, and torsade's de pointes. Other therapeutic applications such as adjunctive therapy in acute asthma exacerbations, acute coronary syndromes, acute cerebral ischemia, and postoperative pain control are under discussion.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Elective open heart surgeries for coronary bypass grafting CABG,valvular lesion single or multiple replacement, combined CABG and valvular; with EF in preoperative echo is more than or equal 40%
排除标准
- •Patients refuse to give informed consent.
- •Emergency open heart surgeries
- •Redo cases.
- •Patients with preoperative serum creatinine level ≥ 1.8 mg/dL
- •Patients with reduced intra/post operative urine output ≤ 1 ml/kg/hour.
- •Patients with Chronic Kidney disease, Renal failure on dialysis
- •Patients with rhythm defects as proved by ECG before administration of Mg/Placebo.
研究组 & 干预措施
Group A (Study group)
After completion of surgical procedure and successful weaning off Cardiopulmonary bypass the patients will be divided into two groups group A will receive 2 gm of Mg Sulfate diluted in 30 cc normal 0.9 % saline via intravenous infusion over 1 hour (1 Mg sulfate ampoule = 10 cc) .
On ICU arrival group A will continue receiving 1 gm of Mg sulfate per hour for five hours via continuous IV infusion.
After 5 hours, group A will receive 200 mg of Mg sulfate per hour for 19 hours via continuous IV infusion, then oral replacement of mag added 1 gm/8 hours tablet.
Total time of Mg/placebo infusion is 24 hours, and oral tablets for 1 week just before hospital discharge.
Total serum Magnesium level will be measured immediately post weaning of cardiopulmonary bypass, on ICU arrival, after 24 and 48 hours.
干预措施: Magnesium sulphate (Drug)
Group B (Control group)
After completion of surgical procedure and successful weaning off Cardiopulmonary bypass the patients will be divided into two groups group B will receive 50 cc normal 0.9 % saline via intravenous infusion over same period.
On ICU arrival group B will same volume and rate of normal saline. After 5 hours, group B will receive same fluid volume and rate of normal saline followed by oral inert starch tablets.
Total time of Mg/placebo infusion is 24 hours, and oral tablets for 1 week just before hospital discharge.
Total serum Magnesium level will be measured immediately post weaning of cardiopulmonary bypass, on ICU arrival, after 24 and 48 hours.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With New Episodes of Atrial Fibrillation
时间窗: 7 days
Count of participants developing atrial fibrillation (AF) (episode \>30 seconds) confirmed by 12-lead ECG or continuous telemetry during hospitalization (≤7 days).
次要结局
- Total Ventilation Time(48 hours)
- Total ICU Length of Stay(From ICU admission until discharge (assessed up to 30 days))
- Number of Participants With New Postoperative Renal Impairment(30 days)
研究者
sarah hamdy
lecturer of Anesthesia, Intensive Care and Pain management
Ain Shams University