心脏骤停中的Levosimendan (LeiCA):一个随机,双盲,II期临床试验的协议
Susanne Rysz1,2, Benjamin Flam1,2, Magnus Hedberg1,2,3
1Perioperative Medicine and Intensive Care, Karolinska University Hospital, Stockholm, Sweden.
Acta anaesthesiologica Scandinavica
|November 25, 2025
概括
这项试点试验调查了levosimendan用于医院外心脏骤停 (OHCA). 结果将指导对这种先进生命支持辅助器进行更大规模的研究.
科学领域:
- 心脏病学 心脏病学
- 紧急医疗 紧急医疗
- 临床试验 临床试验
背景情况:
- 医院外心脏骤停 (OHCA) 结果仍然很差,尽管有先进的生命支持.
- 用于心力衰竭的内扩增剂Levosimendan在心脏骤停模型中显示出前景.
- 心脏骤停中的levosimendan试验 (leica) 试验探讨了levosimendan在耐火OHCA中的作用.
研究的目的:
- 评价levosimendan作为一个附加在耐火OHCA高级生命支持.
- 评估levosimendan在心肺复苏期间的可行性和安全性.
- 为了为最终的多中心试验的设计提供信息.
主要方法:
- 研究者发起的,随机的,双盲的,安慰剂控制的,单中心的试点试验.
- 在斯德哥尔摩,40名患有目击性,耐火性OHCA的成年患者被随机分为3:1接受levosimendan或安慰剂.
- 在心肺复苏期间服用Levosimendan (2.5 mg IV 玻尿酸) 或安慰剂;提供标准的晚期生命维持和复苏后护理.
主要成果:
- 主要终点:30天生存率.
- 二级终点:临床结果的测量.
- 试验注册:ISRCTN15862521;完成日期为2025年10月22日.
结论:
- 该LeiCA试验将调查levosimendan在耐火OHCA中的影响.
- 结果将指导未来的最终多中心试验的设计.
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