Beta-blockade With Landiolol in Out-of-hospital Cardiac Arrest: a Randomized, Double-blind, Placebo-controlled, Pilot Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Time to sustained return of spontaneous circulation (sROSC)
研究概览
简要总结
This study investigates the efficacy of landiolol versus placebo in patients with out-of-hospital cardiac arrest (OHCA) and refractory ventricular fibrillation (electrical storm).
详细描述
The use of beta-blockers in OHCA patients with refractory VF could potentially reverse the unwanted beta-1-mediated effects of endogenous and exogenous epinephrine (proarrhythmic effect), which could in turn lead to a shorter time until return of spontaneous circulation (ROSC).
This is a prospective, double-blind, randomized placebo-controlled pilot trial. The investigators consider this a pilot trial, as this is the first prospective trial evaluating the use of beta-blockade in cardiac arrest.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
study drug preparation by a person not involved in patient recruitment and treatment
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •OHCA , >/=18 years of age
- •3 or more shockable rhythms (VF or pVT) and last rhythm shockable
排除标准
- •Age > 85a
- •Severe head trauma or acute active bleeding
- •Known allergy or insensitivity to landiolol or another beta-blocker
研究组 & 干预措施
Landiolol
initial dose: 20mg target dose: repeated dose (20mg) possible, max. 40mg (total)
干预措施: Landiolol (Drug)
Placebo
Sodium Chlorid 0,9%
干预措施: Sodium Chloride (NaCl) 0.9% (Drug)
结局指标
主要结局
Time to sustained return of spontaneous circulation (sROSC)
时间窗: Time of sROSC or termination of resuscitation efforts
time from bolus infusion of landiolol OR placebo to sROSC
次要结局
- rate of sustained ROSC(Time of sROSC or termination of resuscitation efforts)
- number of shocks until sROSC(Time of sROSC or termination of resuscitation efforts)
- favorable neurologic outcome at hospital discharge, day 28, month 3, 6, 12 (CPC and mRS)(at hospital discharge, day 28, month 3, 6, 12)
- survival at hospital discharge, day 28, month 3, 6, 12(at hospital discharge, day 28, month 3, 6, 12)
- mean/median length of hospital stay(Time of hospital discharge or death)
- survival until hospital admission(Time of hospital admission or death)
- rate of temporary ROSC (any ROSC)(Time of sROSC or termination of resuscitation efforts)
- survival to ICU admission(Time of ICU admission or termination of resuscitation efforts)
- mean/median length of stay in ICU(Time of transfer to open ward or death)
- survival until hospital discharge(Time of hospital discharge or death)
研究者
Michael Holzer
Principal Investigator, Professor of Emergency Medicine
Medical University of Vienna