Caruba Thibaut, Hourton Delphine, Sabatier Brigitte, Rousseau Dominique, Tibi Annick, Hoffart-Jourdain Cécile, Souag Akim, Freitas Nelly, Yjjou Mounia, Almeida Carla, Gomes Nathalie, Aucouturier Pascaline, Djadi-Prat Juliette, Menasché Philippe, Chatellier Gilles, Cholley Bernard
Department of Pharmacy, Hôpital Européen Georges Pompidou, AP-HP, Paris, France.
Clinical Trial Unit and INSERM CIC-141, Hôpital Européen Georges Pompidou, AP-HP, Paris, France.
J Cardiothorac Surg. 2016 Aug 5;11(1):127. doi: 10.1186/s13019-016-0530-z.
Patients with a left ventricular ejection fraction (LVEF) of less than 40 % are at high risk of developing postoperative low cardiac output syndrome (LCOS). Despite actual treatments (inotropic agents and/or mechanical assist devices), the mortality rate of such patients remains very high (13 to 24 %). The LICORN trial aims at assessing the efficacy of a preoperative infusion of levosimendan in reducing postoperative LCOS in patients with poor LVEF undergoing coronary artery bypass grafting (CABG).
METHODS/DESIGN: LICORN study is a multicenter, randomized double-blind, placebo-controlled trial in parallel groups. 340 patients with LVEF ≤40 %, undergoing CABG will be recruited from 13 French hospitals. The study drug will be started after anaesthesia induction and infused over 24 h (0.1 μg/kg/min). The primary outcome (postoperative LCOS) is evaluated using a composite criterion composed of: 1) need for inotropic agents beyond 24 h following discontinuation of the study drug; 2) need for post-operative mechanical assist devices or failure to wean from these techniques when inserted pre-operatively; 3) need for renal replacement therapy. Secondary outcomes include: 1) mortality at Day 28 and Day 180; 2) each item of the composite criterion of the primary outcome; 3) the number of "ventilator-free" days and "out of intensive care unit" days at Day 28.
The usefulness of levosimendan in the perioperative period has not yet been documented with a high level of evidence. The LICORN study is the first randomized controlled trial evaluating the clinical value of preoperative levosimendan in high risk cardiac surgical patients undergoing CABG.
NCT02184819 (ClinicalTrials.gov).
左心室射血分数（LVEF）低于40%的患者术后发生低心排血量综合征（LCOS）的风险很高。尽管采取了实际治疗措施（使用正性肌力药物和/或机械辅助装置），此类患者的死亡率仍然很高（13%至24%）。LICORN试验旨在评估术前输注左西孟旦对降低接受冠状动脉旁路移植术（CABG）且LVEF较差患者术后LCOS发生率的疗效。
方法/设计：LICORN研究是一项多中心、随机双盲、平行组安慰剂对照试验。将从13家法国医院招募340例LVEF≤40%且接受CABG的患者。研究药物将在麻醉诱导后开始输注，并持续24小时（0.1μg/kg/分钟）。主要结局（术后LCOS）采用综合标准进行评估，该标准包括：1）在研究药物停用后24小时以上仍需要使用正性肌力药物；2）术后需要机械辅助装置，或术前插入这些装置后无法撤机；3）需要进行肾脏替代治疗。次要结局包括：1）第28天和第180天的死亡率；2）主要结局综合标准的各项指标；3）第28天“无呼吸机”天数和“转出重症监护病房”天数。
左西孟旦在围手术期的有效性尚未有高水平证据的记录。LICORN研究是第一项评估术前左西孟旦对接受CABG的高危心脏手术患者临床价值的随机对照试验。
NCT02184819（ClinicalTrials.gov）。
