Interest of Levosimendan Preconditioning for Cardiac Surgery Under CEC in Heart Failure Patients With Impaired Ejection Fraction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Major Adverse Cardiac Events (MACE) criteria at 30 days
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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 different University Hospital in France
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
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 different French Hospital, and who have received Levosimendan preoperatively
干预措施: Levosimendan (Drug)
Control - No Levosimendan
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 different French Hospital and who have not received Levosimendan preoperatively
干预措施: No Levosimendan (Drug)
结局指标
主要结局
Major Adverse Cardiac Events (MACE) criteria at 30 days
时间窗: 30 days after Levosimendan exposure
to evaluate the impact of preconditioning with Levosimendan prior to scheduled cardiac surgery with extracorporeal circulation in patients with heart failure and impaired LVEF on the rate of cardiovascular events at 30 days post-op.
次要结局
- major renal events (MAKE) at 30 days from the date of surgery(30 days after Levosimendan exposure)
- On 1-year mortality(1 year after Levosimendan exposure)
- Length of stay in ICU(date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 3 months)
- 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)
- Measurement of left ventricular ejection fraction by cardiac ultrasound at hospital discharge(date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed 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)
- 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)
研究者
Klein Thomas
Principal Investigator
Central Hospital, Nancy, France