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临床试验/NCT04323709
NCT04323709已完成不适用

Levosimendan for Reducing Veno-arterial ECMO Weaning Failure During Refractory Cardiogenic Shock: a Retrospective Propensity Score Analysis

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
VA-ECMO weaning failure defined as death

研究概览

简要总结

Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is a temporary mechanical circulatory support that has been increasingly used over the last decade to restore and maintain adequate end-organ perfusion, with data suggesting improvement in outcome for patients with refractory cardiogenic shock. Nevertheless, VA-ECMO weaning should be questioned every day during patient's support. Indeed, studies have shown that the incidence of severe complications related to ECMO is associated with longer circulatory support duration. Inotropes such as dobutamine are currently used to improve myocardial contractility during VA-ECMO support with the aim to enhance left ventricular ejection, aortic valve opening and to shorten ECMO duration. However, many data suggest an increase in mortality related to predisposition to myocardial ischemia and arrythmias. Levosimendan is a calcium sensitizing inotropic agent with systemic, coronary and pulmonary vasodilatory properties and specific cardioprotective effect without increasing myocardial oxygen consumption. The use of levosimendan in patients undergoing VA-ECMO may therefore be of interest both to reduce the duration of mechanical support and to minimize severe complication with few data suggesting a potential benefit of levosimendan for VA-ECMO weaning and survival in post-cardiotomy low cardiac output syndrome with improvement of endothelial function and hemodynamics. Investigators therefore sought to investigate whether the use of levosimendan improves weaning for patients undergoing VA-ECMO support for refractory cardiogenic shock hospitalized in the surgical intensive care unit (ICU).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥18 years
  • All consecutive patients admitted with VA-ECMO support for refractory cardiogenic shock
  • All consecutive patients admitted for lobectomy or wedge video-assisted thoracoscopy
  • Levosimendan administration was left to the discretion of the attending clinician

排除标准

  • Age < 18 years
  • VA-ECMO duration < 48h
  • VA-ECMO for refractory cardiac arrest
  • Right heart or veno-venous ECMO
  • VA-ECMO for circulatory failure following lung transplant surgery.

结局指标

主要结局

VA-ECMO weaning failure defined as death

时间窗: 24 hours

The primary endpoint was VA-ECMO weaning failure defined as death during ECMO support or death within 24h after ECMO removal.

次要结局

  • Impact of exposure to levosimendan (at day 28)(Day 28)
  • Impact of exposure to levosimendan (at 6 months)(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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