Vasopressin and Methylprednisolone for In-Hospital Cardiac Arrest - A Randomized, Double-Blind, Placebo-Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 501
- 试验地点
- 10
- 主要终点
- Number of Participants With Return of Spontaneous Circulation
研究概览
简要总结
This is an investigator-initiated, multicenter, randomized, placebo-controlled, parallel group, double-blind, superiority trial of vasopressin and methylprednisolone during adult in-hospital cardiac arrest. There will be ten enrolling sites in Denmark. 492 adult patients with in-hospital cardiac arrest receiving at least one dose of adrenaline will be enrolled. The primary outcome is return of spontaneous circulation and key secondary outcomes include survival at 30 days and survival at 30 days with a favorable neurological outcome.
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)
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
- •In-hospital cardiac arrest
- •Age ≥ 18 years
- •Received at least one dose of adrenaline during cardiopulmonary resuscitation
排除标准
- •Clearly documented "do-not-resuscitate" order prior to the cardiac arrest
- •Prior enrollment in the trial
- •Invasive mechanical circulatory support at the time of the cardiac arrest
- •Known or suspected pregnancy at the time of the cardiac arrest
研究组 & 干预措施
Vasopressin and methylprednisolone
The study drugs will consist of 40 mg methylprednisolone (Solu-medrol®, Pfizer) and 20 IU of vasopressin (Empressin®, Amomed Pharma GmbH) given as soon as possible after the first dose of adrenaline. Additional doses of vasopressin (20 IU) will be administered after each adrenaline dose for a maximum of four doses (80 IU).
干预措施: Vasopressin, Arginine (Drug)
Vasopressin and methylprednisolone
The study drugs will consist of 40 mg methylprednisolone (Solu-medrol®, Pfizer) and 20 IU of vasopressin (Empressin®, Amomed Pharma GmbH) given as soon as possible after the first dose of adrenaline. Additional doses of vasopressin (20 IU) will be administered after each adrenaline dose for a maximum of four doses (80 IU).
干预措施: Methylprednisolone (Drug)
Placebo
The placebo for vasopressin will consist of 1 mL of 9 mg/mL NaCl ("normal saline") from 2 mL ampules identical to the vasopressin ampules. The placebo for methylprednisolone will also consist of 1 mL of 9 mg/mL NaCl.
干预措施: NaCl (Drug)
结局指标
主要结局
Number of Participants With Return of Spontaneous Circulation
时间窗: During the cardiac arrest, an average of 20 minutes
Return of spontaneous circulation is defined as spontaneous circulation with no further need for chest compressions sustained for at least 20 minutes
次要结局
- Number of Participants That Survived 30 Days(At 30 days)
- Number of Participants With a Favorable Neurological Outcome at 30 Days(At 30 days)
研究者
Lars Wiuff Andersen
Associate Professor
Aarhus University Hospital