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临床试验/NCT05685537
NCT05685537招募中不适用

Impact of Levosimendan Preconditioning on Critical Care and In-hospital Lengths of Stay After Cardiac Surgery With Bypass Surgery

Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年12月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
120
试验地点
1
主要终点
Length of stay in ICU

研究概览

简要总结

Levosimendan, a drug with inotropic, vasodilatory and myocardial protective properties, has been proposed for the prevention and treatment of postoperative low cardiac output syndrome in cardiac surgery. Despite preliminary studies with promising results, large randomized controlled trials aimed at demonstrating the benefits of levosimendan did not show superiority over placebo in this indication. However, in these studies, the infusion was neither performed at the maximum dosage nor during the 24 hours preceding the surgery, but mainly at the very beginning of the operation. However, post hoc analyses showed a reduction in mortality and in the occurrence of low cardiac output syndrome in the subgroup of patients who had undergone isolated coronary artery bypass grafting, in contrast to those who had undergone valvular or combined surgery. Another recent study suggests that under similar conditions, preconditioning with levosimendan started 48 hours before surgery reduces the length of stay in intensive care and the average cost of hospitalization. There are no formal recommendations on the prophylactic use of levosimendan in cardiac surgery for heart failure patients with impaired LVAS. However, the France-Levo registry, a multicenter observational study requested by the HAS, has shown that in real practice there is a place for preconditioning with levosimendan, which is used in this indication for 7% of the patients in the registry. The Cardiovascular Surgery and Transplantation Department of the Nancy Brabois University Hospital, which actively participated in the France-Levo registry, is one of the cardiac surgery centers that uses this practice, as is the University Hospital of Rouen. It is interesting to be able to evaluate retrospectively whether levosimendan preconditioning has a positive impact on the postoperative prognosis of patients and more particularly on the reduction of the length of stay in critical care and in hospital compared to standard management.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with heart failure impaired LVEF (< 40%), who have undergone left heart surgery (coronary artery bypass grafting and/or mitral and/or aortic valve replacement) under extracorporeal circulation between 01/01/2018 and 28/02/2022 at the Nancy University Hospital or the University Hospital of Rennes, Rouen or Amiens

排除标准

  • Initiation of levosimendan > 48 hours or < 24 hours before surgery
  • ECMO pre- or post-op

研究组 & 干预措施

Levosimendan - Interventional

Major patients in heart failure with impaired LVEF (< 40%) who have undergone left heart surgery (coronary artery bypass grafting and/or mitral and/or aortic valve replacement) under extracorporeal circulation between 01/01/2018 and 28/02/2022 at the Nancy University Hospital or at the University Hospital of Rennes, Rouen or Amiens, and who have received Levosimendan preoperatively

干预措施: Levosimendan (Drug)

结局指标

主要结局

Length of stay in ICU

时间窗: date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 3 months

To evaluate the impact of levosimendan preconditioning preoperatively for cardiac surgery on critical care length of stay in patients with heart failure with impaired preoperative LVAS.

次要结局

  • severity of postcardiotomy cardiogenic shock and/or postoperative vasoplegia using the score Vasoactive Inotropic Score (VIS)(date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 3 months)
  • readmission rate for cardiac decompensation(within one year of Levosimendan administration)
  • On 1-year mortality(1 year after Levosimendan exposure)
  • the total length of hospital stay(start date of hospitalization in intensive care to the date of discharge from conventional sectors evaluated up to 3 months)
  • duration of catecholamine use after surgery(date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 3 months)
  • left ventricular systolic function at hospital discharge(date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 3 months)
  • acute renal failure postoperatively(on discharge from the intensive care unit)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Principal Investigator
主要研究者

Klein Thomas

Medical Doctor

Central Hospital, Nancy, France

研究点 (1)

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