Kimmoun Antoine, O'Brien Connor, Blumer Vanessa, Wenzl Florian A, Pöss Janine, Zeymer Uwe, Møller Jacob E, Aissaoui Nadia, Sinha Shashank S, Combes Alain, Sato Naoki, Sionis Alessandro, Soussi Sabri, Price Susanna, Monroe Rhonda E, Mathew Rebecca, Mebazaa Alexandre
Lorraine University, Nancy Teaching Hospital, Intensive care unit, INSERM U1116, Nancy, France.
Division of Cardiology, Department of Medicine, University of California, San Francisco, San Francisco, CA, USA.
Lancet Respir Med. 2025 Sep;13(9):833-842. doi: 10.1016/S2213-2600(25)00084-0. Epub 2025 May 5.
Despite substantial advancements in the management of cardiogenic shock, mortality rates remain greater than 40%. Trials have shown that increasing survival rates in cardiogenic shock is challenging. Even the most successful trials show 5-15% reductions in mortality, and gains have been restricted to acute myocardial infarction cardiogenic shock, representing approximately 5% of the population with cardiogenic shock. Trials studying pharmacological strategies in all populations with cardiogenic shock have been consistently neutral or negative. The reasons are complex and include heterogeneity in cardiogenic shock phenotypes, timing of patient inclusion, high prevalence of multiorgan failure and cardiac arrest, and unrealistic estimated treatment effects that restrict sample size with sometimes inadequate funding leading to underpowered trials. In June, 2024, international experts from the fields of cardiology, anaesthesiology, critical care medicine, biostatistics, government regulation of trials, and patient advocacy convened at the sixth Critical Care Clinical Trialists Workshop to reflect on how to improve the design of future randomised clinical trials in cardiogenic shock. This Position Paper summarises the results of discussions regarding what an optimal randomised controlled trial on cardiogenic shock should entail in terms of population selection, primary objectives, statistical analysis, and incorporation of the patient's perspective.
尽管在心源 性休克的治疗方面取得了重大进展，但死亡率仍超过40%。试验表明，提高心源性休克的生存率具有挑战性。即使是最成功的试验也显示死亡率降低了5%-15%，而且这些成果仅限于急性心肌梗死所致的心源性休克，约占心源性休克患者总数的5%。针对所有心源性休克患者群体研究药物治疗策略的试验一直处于中性或阴性结果。原因很复杂，包括心源性休克表型的异质性、患者纳入的时机、多器官功能衰竭和心脏骤停的高发生率，以及不切实际的估计治疗效果，这些因素限制了样本量，有时还因资金不足导致试验效能低下。2024年6月，来自心脏病学、麻醉学、重症医学、生物统计学、试验的政府监管以及患者权益倡导等领域的国际专家齐聚第六届重症医学临床试验研讨会，思考如何改进未来心源性休克随机临床试验的设计。本立场文件总结了关于心源性休克最佳随机对照试验在人群选择、主要目标、统计分析以及纳入患者观点等方面的讨论结果。
