BackgroundThe administration of levosimendan prophylactically to patients undergoing cardiac surgery remains a controversial practice, and few studies have specifically assessed the value of this approach in pediatric patients. This study therefore sought to explore the safety and efficacy of prophylactic levosimendan administration to pediatric patients as a means of preventing low cardiac output syndrome (LCOS) based upon hemodynamic, biomarker, and pharmacokinetic readouts.MethodsThis was a single-center, double-blind, randomized, placebo-controlled trial. Patients ≤ 48 months old were enrolled between July 2018 and April 2019 and were randomly assigned to groups that received either placebo or levosimendan infusions for 48 h post-surgery, along with all other standard methods of care. LCOS incidence was the primary outcome of this study.ResultsA total of 187 patients were enrolled, of whom 94 and 93 received levosimendan and placebo, respectively. LCOS incidence did not differ significantly between the levosimendan and placebo groups (10 [10.6%] versus 18 [19.4%] patients, respectively; 95% confidence interval [CI] 0.19–1.13; p = 0.090) nor did 90-day mortality (3 [3.2%] versus 4 [4.3%] patients, CI 0.14–3.69, p = 0.693), duration of mechanical ventilation (median, 47.5 h and 39.5 h, respectively; p = 0.532), ICU stay (median, 114.5 h and 118 h, respectively; p = 0.442), and hospital stay (median, 20 days and 20 days, respectively; p = 0.806). The incidence of hypotension and cardiac arrhythmia did not differ significantly between the groups. Levels of levosimendan fell rapidly without any plateau in plasma concentrations during infusion. A multiple logistic regression indicated that randomization to the levosimendan group was a predictor of LCOS.ConclusionsProphylactic levosimendan administration was safe in pediatric patients and had some benefit to postoperative hemodynamic parameters, but failed to provide significant benefit with respect to LCOS or 90-day mortality relative to placebo.Trial registrationName of the registry: Safety evaluation and therapeutic effect of levosimendan on the low cardiac output syndrome in patients after cardiopulmonary bypass. Trial registration number: ChiCTR1800016594. Date of registration: 11 June 2018. URL of trial registry record: http://www.chictr.org.cn/index.aspx

中文翻译：

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接受心脏手术的儿科患者预防性使用左西孟旦：一项前瞻性随机对照试验


背景对接受心脏手术的患者预防性给予左西孟旦仍然是一个有争议的做法，很少有研究专门评估这种方法在儿科患者中的价值。因此，本研究旨在根据血流动力学、生物标志物和药代动力学读数，探讨儿科患者预防性给予左西孟旦作为预防低心输出量综合征 (LCOS) 的安全性和有效性。方法这是一项单中心、双盲、随机、安慰剂对照试验。 2018 年 7 月至 2019 年 4 月期间纳入≤ 48 个月大的患者，并随机分配到术后 48 小时接受安慰剂或左西孟旦输注以及所有其他标准护理方法的组。 LCOS 发生率是本研究的主要结局。结果 共有 187 名患者入组，其中 94 名患者接受左西孟旦治疗，93 名患者接受安慰剂治疗。左西孟旦组和安慰剂组之间的 LCOS 发生率没有显着差异（分别为 10 例 [10.6%] 和 18 例 [19.4%] 患者；95% 置信区间 [CI] 0.19–1.13；p = 0.090），90 天死亡率也没有显着差异（ 3 例 [3.2%] 与 4 例 [4.3%] 患者比较，CI 0.14–3.69，p = 0.693），机械通气持续时间（中位值分别为 47.5 小时和 39.5 小时；p = 0.532），ICU 住院时间（中位值，114.5 小时）和 118 小时，分别；p = 0.442），以及住院时间（中位数，分别为 20 天和 20 天；p = 0.806）。低血压和心律失常的发生率在各组之间没有显着差异。输注期间左西孟旦的水平迅速下降，血浆浓度没有任何平台。多重逻辑回归表明左西孟旦组的随机化是 LCOS 的预测因素。结论 与安慰剂相比，预防性给予左西孟旦在儿科患者中是安全的，并且对术后血流动力学参数有一定益处，但在 LCOS 或 90 天死亡率方面未能提供显着益处。 试验注册登记名称：左西孟旦对儿童患者的安全性评估和治疗效果体外循环术后患者的低心输出量综合征。试验注册号：ChiCTR1800016594。注册日期：2018年6月11日。试用注册记录网址：http://www.chictr.org.cn/index。ASPX