Naloxone for In-Hospital Cardiac Arrest
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- Region Skane
- 入组人数
- 850
- 主要终点
- 30-day survival
研究概览
简要总结
The goal of this clinical trial is to learn if the drug naloxone in addition to cardiopulmonary resuscitation improves outcomes of in-hospital cardiac arrets. The main questions it aims to answer are:
Does naloxone improve survival after the cardiac arrest? Does naloxone improve functional outcome in survivors of cardiac arrest? Does naloxone improve health related quality of life after the cardiac arrest? How common are adverse reactions to naloxone when administered during cardiopulmonary resuscitation.
Researchers will compare naloxone to a placebo (a look-alike substance that contains no drug) to see if naloxone works during 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)
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 CPR
排除标准
- •"Do-not-resuscitate"-order
- •Known/suspected pregnancy
- •Known objection by the patient to participate in the trial
- •Previous inclusion in the trial
研究组 & 干预措施
placebo
干预措施: Placebo (Drug)
naloxone
干预措施: naloxone (Drug)
结局指标
主要结局
30-day survival
时间窗: 30 days after the cardiac arrest
proportion of patients alive
次要结局
未报告次要终点
研究者
Anna Lybeck
associate professor & senior consultant, anesthetics and intensive care
Region Skane