Prospective Randomized Study of Efficacy and Safety of 1c Class Antiarrhythmic Agent (Propafenone) in Septic Shock
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- Efficacy of propafenone
研究概览
简要总结
Arrhythmias accompany septic shock in increased rates than in other ICU cohorts and their presence and management are related to patient´s prognosis. 1c class antiarrhythmics are seldom administered in intensive care due to a dose dependent toxicity published in case reports and unfavourable outcome reported in a few prospective trials done on cardiology patients. The papers on 1c class antiarrhythmics do not take into consideration a complex haemodynamic assessment using echocardiography. The authors have recently presented a retrospective study on SV arrhythmias in septic shock patients demonstrating favourable effect and safety of propafenone which showed higher antiarrhythmic efficacy than amiodarone.
详细描述
Primary aim is to verify the conclusions of the retrospective study, i.e. efficacy and safety of propafenone, in a prospective blinded randomized trial performed in two large intensive care units. Secondary aims are to monitor the electromechanics of left atrium in patients with SV arrhythmias in septic shock.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
Provided by a dedicated study nurse
入排标准
- 年龄范围
- 16 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Septic shock with a new onset SV arrhythmia
- •LV systolic function normal to moderately reduced according to echocardiography.
排除标准
- •Severe LV systolic dysfunction
- •More than 1st degree AV block
- •High dose vasopressor therapy with continuous noradrenaline > 1.0 ug/kg.min
- •Known intolerance to amiodarone or propafenone
- •Absence of septic shock
- •Chronic AF
- •Dependence on pacemaker
- •Status after MAZE procedure
研究组 & 干预措施
Propafenone i.v.
Patients in septic shock with a new onset supraventricular arrhythmia are randomized either to arm treated with propafenone or with amiodarone. Both arms will have standard treatment, there are no limits to indicated electric cardioversion as part of treatment.
Intervention: Bolus of 35-70 mg intravenous propafenone followed by continuous infusion of 400-840 mg/24h.
干预措施: Propafenone i.v. (Drug)
Amiodarone i.v.
Patients in septic shock with a new onset supraventricular arrhythmia are randomized either to arm treated with propafenone or with amiodarone. Both arms will have standard treatment, there are no limits to indicated electric cardioversion as part of treatment.
Intervention: Bolus of 150-300 mg of intravenous amiodarone followed by continuous infusion of 600-1800 mg/24h.
干预措施: Amiodarone i.v. (Drug)
结局指标
主要结局
Efficacy of propafenone
时间窗: 1 year
cardioversion rate
ICU mortality of septic shock patients on propafenone for a SV arrhythmia
时间窗: 1 year
ICU mortality
28-day mortality of septic shock patients on propafenone for a SV arrhythmia
时间窗: 2 years
28-day mortality
12-month mortality of septic shock patients on propafenone for a SV arrhythmia
时间窗: 2 years
12-month mortality
次要结局
- Electromechanics of left atrium(1 year)
- Electromechanics of LA(1 year)
研究者
Martin Balik
A/Prof, MD, PhD
Charles University, Czech Republic