持续深度镇静与心脏骤停和复苏后的最小镇静 (SED-CARE):一个随机临床试验的协议
A Ceric1, J Dankiewicz2, J Hästbacka3
1Anesthesia and Intensive Care, Department of Clinical Sciences, Lund University, Skane University Hospital, Malmö, Sweden.
Acta anaesthesiologica Scandinavica
|April 3, 2025
概括
这项试验旨在调查深度镇静是否能改善心脏骤停患者的生存率. 持续的深度镇静 (RASS -4/-5) 与心脏骤停后36小时的最小镇静 (RASS 0至 -2) 相比较.
科学领域:
- 关键护理医学 关键护理医学
- 心脏病学 心脏病学
- 神经学 神经学
背景情况:
- 镇静通常用于医院外心脏骤停 (OHCA) 幸存者进行停顿后护理.
- 关于心脏骤停后常规深度镇静的益处或危害的证据有限.
- 该SED-CARE试验通过比较深度与最小镇静策略来解决这一差距.
研究的目的:
- 确定持续深度镇静与最小镇静对复苏的OHCA患者患者患者重要结果的影响.
- 在随机化后6个月评估死亡率和功能结果.
- 评估严重不良事件和患者报告的健康状况.
主要方法:
- 这项SED-CARE试验是较大的STEPCARE因数试验的一部分.
- 昏迷的OHCA幸存者恢复自发循环 (ROSC) 被随机分配到深度 (RASS -4/-5) 或最小 (RASS 0至 -2) 镇静36小时.
- 主要结局是6个月的全因死亡率;次要结局包括功能状态和不良事件.
主要成果:
- 该研究旨在检测5.6%的绝对风险降低死亡率.
- 招生目标为3500名参与者,90%的人口.
- 关于死亡率,功能结果和不良事件的结果正在等待试验完成.
结论:
- 该SED-CARE试验将提供关于OHCA幸存者的深度镇静疗法的疗效的关键数据.
- 它旨在确定深度镇静 (RASS -4/-5) 与最小镇静 (RASS 0至 -2) 相比,是否提供死亡率的好处.
- 这些发现将指导心脏骤停后的治疗方案,以控制镇静剂的使用.
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