Comparative Study of the Antiarrhythmic and Cardioprotective Effects of Atorvastatin Versus Magnesium Sulfate in Cardiac Valve Replacement Surgery
试验速览
- 阶段
- 4 期
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Postoperative atrial fibrillation
研究概览
简要总结
This study aims to compare the antiarrhythmic and cardioprotective effects of Atorvastatin versus Magnesium Sulfate after Cardiac valve Replacement Surgery
详细描述
Arrhythmia is a common complication after cardiac valve surgery. Postoperative atrial fibrillation (POAF) is the most common type of arrhythmia after cardiac surgery. It has different leading causes, including myocardial injury, inadequate myocardial protection, the effect of cardiopulmonary bypass, and electrolyte imbalance. Beta blockers, amiodarone, and magnesium sulfate are used for the management of POAF.
Statin is used commonly for its lipid lowering action, however, some studies shows that statin has powerful pleiotropic effects including its antiarrhythmic effect.
This study aims to compare the antiarrhythmic and cardioprotective effects of Atorvastatin versus magnesium sulfate after cardiac replacement 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)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing isolated valvular replacement surgery.
- •Preoperative rhythm: Sinus rhythm.
- •Preoperative troponin I < 0.01 ng/mL.
- •Normal lipid profile.
- •White blood cells (4-11 X 103/mm3).
- •Preoperative C-reactive protein < 3 mg/L.
排除标准
- •History of atrial fibrillation.
- •Any degree of heart block or patients with implanted pacemaker.
- •Prior use of Antiarrhythmic drugs.
- •Preoperative lipid lowering therapy (e.g statins) during the last 3 months.
- •Previous treatment with any type of magnesium containing supplementation (the week before the intervention).
- •Underlying heart failure or Left ventricular ejection fraction < 0.
- •Previous myocardial infarction.
- •Diabetes or other metabolic disorders.
- •Renal diseases.
- •Hepatic dysfunction.
- •Underlying thyroid problems (hypo/hyperthyroidism).
- •Underlying inflammatory disease (active or controlled)
- •Immunosuppressive and anti-inflammatory medications for the treatment of coexisting conditions.
- •Psychological disorders,
- •Emergency cardiac surgery
研究组 & 干预措施
Atorvastatin
Atorvastatin and intravenous placebo
干预措施: Atorvastatin (Drug)
Atorvastatin
Atorvastatin and intravenous placebo
干预措施: intravenous placebo (Other)
Magnesium sulfate
Magnesium sulfate and tablets placebo
干预措施: Magnesium Sulfate (Drug)
Magnesium sulfate
Magnesium sulfate and tablets placebo
干预措施: tablets placebo (Other)
Control
intravenous placebo and tablet placebo
干预措施: intravenous placebo (Other)
Control
intravenous placebo and tablet placebo
干预措施: tablets placebo (Other)
结局指标
主要结局
Postoperative atrial fibrillation
时间窗: Five days
The occurrence of postoperative atrial fibrillation (POAF)
次要结局
未报告次要终点
研究者
FATMA NABIL AHMED MOHAMED
Assistant lecturer of anesthesia and intensive care, Assiut University
Assiut University