LEVOECMO试验组和国际ECMO网络（ECMONet）Etienne de Montmollin团队近日取得一项新成果。经过不懈努力，他们的最新研究探明了左西孟旦促进严重心源性休克患者脱离ECMO支持：LEVOECMO随机临床试验。这一研究成果于2025年12月1日发表在国际顶尖学术期刊《美国医学会杂志》上。

重要性：左西孟旦可能促进静脉-动脉体外膜氧合（VA-ECMO）的脱机并提高生存率，但支持证据仍然有限。

目的：评估早期给药左西孟旦是否能减少严重但可能可逆的心源性休克患者成功VA-ECMO脱机的时间。

设计、设置和参与者：随机、双盲、安慰剂对照试验在法国11个重症监护病房（icu）进行。在2021年8月27日至2024年9月10日期间，纳入205名在48小时前开始VA-ECMO的急性心源性休克成年患者。最后的后续工作于2024年11月10日完成。

干预措施：患者按1:1比例随机接受左西孟旦治疗，剂量为每分钟0.15 μg/kg， 2小时后增加至每分钟0.20 μg/kg（n=101)或安慰剂（n = 104）。

主要成果和措施：主要终点是随机分组后30天内ECMO成功脱机的时间。次要结局包括ECMO、机械通气和器官无衰竭天数、ICU和住院时间、严重不良事件、全因30天和60天死亡率。

结果：205例随机患者（中位年龄58 [IQR， 50-67]岁，男性149[72.7%]），主要的心源性休克病因为开心术后（79[38.5%]）、急性心肌梗死（56[27.3%]）、心肌炎（28[13.7%]）。左西孟旦组93%的患者和安慰剂组96%的患者治疗剂量增加到0.20±0.01 μg/kg / min。30天内，左西孟旦组101例患者中有69例（68.3%）成功脱机，而安慰剂组104例患者中有71例（68.3%）成功脱机（风险差异为0.0%；亚分布风险比为1.02;P = 0.92）。左西孟旦组和安慰剂组中位ECMO持续时间分别为5 [IQR， 4-7]天和6 [IQR， 4-11]天；P =53)，平均ICU住院时间(18 [SD， 15]天vs 19 [SD， 15]天；P =42)和60天死亡率(27.7% vs 25.0%；风险差，2.7%;P =78)无显著差异。左西孟旦组室性心律失常发生率更高（18例[17.8%]vs 9例[8.7%]；绝对风险差为9.2%[95%CI，0.4%-18.1%]）。

研究结果表明，在VA-ECMO支持的严重但可能可逆的心源性休克患者中，与安慰剂相比，早期左西孟旦给药并没有显著缩短ECMO成功脱机的时间。

附：英文原文

Title: Levosimendan to Facilitate Weaning From ECMO in Patients With Severe Cardiogenic Shock: The LEVOECMO Randomized Clinical Trial

Author: Alain Combes, Ouriel Saura, Nicolas Nesseler, Said Lebbah, Bertrand Rozec, Bruno Levy, Jean-Luc Fellahi, Antoine Beurton, Simon Meslin, Philippe Gaudard, Adrien Bouglé, André Vincentelli, Romain Sonneville, Guillaume Lebreton, David Lévy, Alexandre Ouattara, Florence Tubach, LEVOECMO Trial Group and the International ECMO Network (ECMONet), Juliette CHOMMELOUX, Grégoire DEL MARMOL, Guillaume HEKIMIAN, Pascal LEPRINCE, Charles-Edouard LUYT, Quentin MOYON, Marc PINETON, Matthieu SCHMIDT, Nima Djavidi, Corinne Batsale, Thibaud Besnard, Franois-Xavier Hérion, Julien Imbault, Laure Maudiere, Claire Oddos, Mathieu Pernot, Simon Veyret, Najla DACHRAOUI, Florence GIMBERT, Hélène NOUGUE, Paul ACHOUH, Bernard CHOLLEY, Delphine CHESNEL, Léa DIDIER, Matthias JACQUET-LAGREZE, Martin RUSTE, Joseph PIERRE, Aurore Ughetto, Hélène David, Marc Mourad, Cinderella Blin, Sebastien Biedermann, Xavier Buzin, Erwan Flécher, Grégoire Le Gac, Alexandre Mansour, Antoine Kimmoun, Pierre Perez, Clement Haddadi, Carine Thivillier, Thomas Klein, Arthur Bailly, Philippe Bizouarn, Julien Cadiet, Nicolas Groleau, Thierry Lepoivre, Johanna Nicolet, Fouzia Souab, Mickal Vourch, Marie Jungling, Etienne de Montmollin

Issue&Volume: 2025-12-01

Abstract: Importance  Levosimendan may facilitate weaning from venoarterial extracorporeal membrane oxygenation (VA-ECMO) and improve survival, but supporting evidence remains limited.

Objective  To assess whether early administration of levosimendan reduces the time to successful VA-ECMO weaning in patients with severe but potentially reversible cardiogenic shock.

Design, Setting, and Participants  Randomized, double-blind, placebo-controlled trial conducted across 11 intensive care units (ICUs) in France. Between August 27, 2021, and September 10, 2024, 205 adult patients with acute cardiogenic shock who had started VA-ECMO in the preceding 48 hours were enrolled. Final follow-up was completed on November 10, 2024.

Interventions  Patients were randomized in a 1:1 ratio to receive levosimendan, 0.15 μg/kg per minute, to be increased to 0.20 μg/kg per minute after 2 hours (n=101), or placebo (n=104).

Main Outcomes and Measures  The primary outcome was time to successful ECMO weaning within 30 days following randomization. Secondary outcomes included ECMO-, mechanical ventilation–, and organ failure–free days, ICU and hospital lengths of stay, serious adverse events, and all-cause 30- and 60-day mortality.

Results  Among the 205 randomized patients (median age, 58 [IQR, 50-67] years; 149 [72.7%] male), main cardiogenic shock etiologies were postcardiotomy (79 [38.5%]), acute myocardial infarction (56 [27.3%]), and myocarditis (28 [13.7%]). Treatment dose was increased to 0.20 ± 0.01 μg/kg per minute in 93% of patients receiving levosimendan and in 96% of those receiving placebo. Within 30 days, 69 of 101 patients (68.3%) had a successful ECMO weaning in the levosimendan group compared with 71 of 104 (68.3%) in the placebo group (risk difference, 0.0% [95% CI, 12.8% to 12.7%]; subdistribution hazard ratio, 1.02 [95% CI, 0.74-1.39]; P=.92). In the levosimendan and placebo groups, respectively, median ECMO duration (5 [IQR, 4-7] days vs 6 [IQR, 4-11] days; P=.53), mean ICU length of stay (18 [SD, 15] days vs 19 [SD, 15] days; P=.42), and 60-day mortality (27.7% vs 25.0%; risk difference, 2.7% [95% CI, 9.0% to 15.3%]; P=.78) did not differ significantly. Ventricular arrhythmias occurred more frequently with levosimendan (18 [17.8%] vs 9 [8.7%]; absolute risk difference, 9.2% [95% CI, 0.4%-18.1%]).

Conclusions and Relevance  Among patients with severe but potentially reversible cardiogenic shock supported by VA-ECMO, early levosimendan administration did not significantly reduce the time to successful weaning of ECMO compared with placebo.

DOI: 10.1001/jama.2025.19843

Source: https://jamanetwork.com/journals/jama/fullarticle/2842189