The Use of Amiodarone vs. Lidocaine and Placebo for the Prevention of Ventricular Fibrillation After Myocardial Reperfusion During Cardiopulmonary Bypass
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 342
- 试验地点
- 1
- 主要终点
- Participants Experiencing Ventricular Fibrillation Requiring Defibrillation During the 60 Minute Period Following Myocardial Reperfusion
研究概览
简要总结
This was a prospective, randomized, double blinded study in which patients undergoing a cardiopulmonary bypass (CPB) with aortic cross clamping were randomly assigned to receive amiodarone, lidocaine, or saline placebo prior to removal of the aortic cross clamp. (CPB is a technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the body.) Specifically, we will test the hypothesis that amiodarone is superior to both lidocaine and placebo in the prevention of a severely abnormal heart rhythm when the blood flow is restored to the heart after the aortic cross clamp is removed.
详细描述
This was a prospective, randomized, double blinded study in which patients undergoing cardiopulmonary bypass with aortic cross clamping were randomly assigned to receive amiodarone, lidocaine, or saline placebo prior to removal of the aortic cross clamp. Specifically, we will test the hypothesis that amiodarone administration decreases the incidence of ventricular fibrillation, the number of defibrillation attempts and the total energy and current required for defibrillation should ventricular fibrillation occur.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing cardiac surgery that was expected to include cross-clamping of the aorta
排除标准
- •Women wishing to become pregnant within 6 months of surgery
- •Allergy to amiodarone
- •History of organ dysfunction due to previous amiodarone use
- •Patients who require more than mild systemic hypothermia (<32 degrees C) during cardiopulmonary bypass
- •Patients who require more than one bypass run or more than one period of aortic cross-clamping
研究组 & 干预措施
Lidocaine 1.5 mg /kg
Lidocaine is a class I (sodium channel block) antiarrhythmic drug.
干预措施: Lidocaine (Drug)
Amiodarone 300 mg
Amiodarone is used to treat and prevent certain types of serious, life-threatening ventricular arrhythmias (a certain type of abnormal heart rhythm) when other medications did not help or could not be tolerated. Amiodarone is in a class of medications called antiarrhythmics. It works by relaxing overactive heart muscles.
干预措施: Amiodarone (Drug)
placebo (saline)
干预措施: Placebo (Drug)
结局指标
主要结局
Participants Experiencing Ventricular Fibrillation Requiring Defibrillation During the 60 Minute Period Following Myocardial Reperfusion
时间窗: Participants were followed from randomization through the 60 minute period following myocardial reperfusion.
次要结局
- Number of Defibrillation Attempts(Participants were followed from randomization through the 60 minute period following myocardial reperfusion.)
- Incidence of Arrhythmias Other Than Ventricular Fibrillation(Participants were followed from randomization through the 60 minute period following myocardial reperfusion.)
- Incidence of Arrhythmias in the Post-Operative Period(Participants were followed from dismissal from the ICU until dismissal from the hospital.)
- Use of Vasopressors(Participants were followed from randomization until time to discharge from the hospital.)
- Time to Discharge From the Intensive Care Unit(Participants were followed from the date of randomization until the date of discharge from the Intensive Care Unit, assessed up to 40 days.)
- Time to Discharge From the Hospital(Participants were followed from the date of randomization until the date of discharge from the hospital, assessed up to 60 days.)