Calcium for Out-of-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
- 397
- 试验地点
- 1
- 主要终点
- Number of Participants With Sustained 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 calcium during adult out-of-hospital cardiac arrest. 430 adult patients with out-of-hospital cardiac arrest receiving at least one dose of adrenaline will be enrolled. The primary outcome is sustained 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
- •Out-of-hospital cardiac arrest
- •Age ≥ 18 years
- •Received at least one dose of adrenaline
排除标准
- •Traumatic cardiac arrest - including drowning and external asphyxia (e.g., hanging, strangulation, or foreign object airway obstruction)
- •Known or strongly suspected pregnancy
- •Prior enrollment in the trial
- •Received adrenaline during cardiac arrest before arrival of prehospital personnel with the study drug
- •Clinical indication for calcium administration during the cardiac arrest
研究组 & 干预措施
Calcium
The intervention will consist of 5 mmol (10 mL ampoule) of calcium chloride (CaCl2) administered intravenously or intraosseously immediately after the first dose of adrenaline and again after the second dose of adrenaline.
干预措施: Calcium Chloride (Drug)
Placebo
The placebo will consist of 10 mL of 9 mg/mL sodium chloride (NaCl, "normal saline") administered intravenously or intraosseously immediately after the first dose of adrenaline and again after the second dose of adrenaline.
干预措施: Sodium chloride 0.9% (Drug)
结局指标
主要结局
Number of Participants With Sustained Return of Spontaneous Circulation
时间窗: Before or after hospital arrival (up to 2 hours after the cardiac arrest)
Palpable pulses or other signs of circulation without a need for chest compressions lasting at least 20 minutes.
次要结局
- Number of Participants With 30-day Survival(30 days after the cardiac arrest)
- Number of Participants With 30-day Favorable Neurological Outcome(30 days after the cardiac arrest)
研究者
Lars Wiuff Andersen
Associate Professor
Aarhus University Hospital