Preoperative Infusion of Levosimendan in High Risk Cardiac Surgery Patients: A Retrospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- hours of mechanical ventilation
研究概览
简要总结
The aim of this retrospective study will be to investigate the effect of the preoperative administration of levosimendan on the outcome of patients with compromised cardiac function undergoing cardiac surgery
详细描述
Patients with severely reduced left ventricular ejection fraction (LVEF) face a high risk of morbidity and mortality after cardiac surgery. Impaired cardiac function preoperatively predisposes patients to low cardiac output syndrome. Levosimendan acts by a different mechanism than traditional inotropes and its preoperative use could improve the outcome of patients with cardiac failure. Specifically, it promotes vasodilation of coronary, pulmonary and systemic vessels, has an anti-inflammatory and anti-oxidant effect and enhances cardiac contractility by improving the response of the myofilaments to intracellular calcium.
The aim of this retrospective study will be to investigate the effect of the preoperative administration of levosimendan on the outcome of patients with compromised cardiac function undergoing cardiac surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •elective cardiac surgery
- •cardiac surgery under cardiopulmonary bypass
- •low ejection fraction (<40%)
排除标准
- •age <18 years old
- •urgent operation
- •glomerular filtration rate<30 ml/min
- •hepatic dysfunction preoperatively
- •side effects (hypotension, tachycardia, ST segment abnormalities during levosimendan administration
- •redo surgery
结局指标
主要结局
hours of mechanical ventilation
时间窗: during stay in ICU, approximately 48 hours postoperatively
hours of mechanical ventilation during patient stay in Intensive Care Unit (ICU)
vasopressor use in operating room
时间窗: intraoperatively, from induction to end of anesthesia, an average period of 3 hours
need for vasopressor use, yes or no
incidence of renal dysfunction
时间窗: postoperatively, an average period of 7-10 days
development of new-onset renal dysfunction, defined as an increase in creatinine levels over 0.3 mg/dL from the initial values
need of mechanical assist devices intraoperatively
时间窗: intraoperatively, from induction to end of anesthesia, an average period of 3 hours and postoperatively, an average period of 7-10 days
need for mechanical assist devices, yes or no
need of mechanical assist devices postoperatively
时间窗: postoperatively, an average period of 7-10 days
need for mechanical assist devices, yes or no
change from baseline in cardiac output (CO)
时间窗: 10 minutes after anesthesia induction, 10 minutes after bypass discontinuation, end of operation (an average period of 3 hours after start of surgery), 12 hours after ICU admittance, 24 hours after ICU admittance,
a Swan-Ganz catheter will be used for hemodynamic measurements
vasopressor use in ICU
时间窗: during stay in ICU, approximately 48 hours postoperatively
need for vasopressor use, yes or no
inotrope use in operating room
时间窗: intraoperatively, from induction to end of anesthesia, an average period of 3 hours
need for inotrope use, yes or no
inotrope use in ICU
时间窗: during stay in ICU, approximately 48 hours postoperatively
need for inotrope use, yes or no
length of ICU stay
时间窗: postoperatively, an average period of 7-10 days
duration of patient stay in ICU in days
incidence of arrhythmias
时间窗: postoperatively, an average period of 7-10 days
development of new-onset arrhythmias, yes or no
hospitalization time
时间窗: postoperatively, up to 20 days after the operation
duration of hospital stay after surgery in days
incidence of death within the first 30 days after surgery
时间窗: 30 days after surgery
patient survival within the first 30 days after surgery, yes or no
change from baseline in mean arterial pressure (MAP)
时间窗: 10 minutes after anesthesia induction, 10 minutes after bypass discontinuation, end of operation (an average period of 3 hours after start of surgery), 12 hours after ICU admittance, 24 hours after ICU admittance,
a Swan-Ganz catheter will be used for hemodynamic measurements
change from baseline in mean pulmonary arterial pressure (MPAP)
时间窗: 10 minutes after anesthesia induction, 10 minutes after bypass discontinuation, end of operation (an average period of 3 hours after start of surgery), 12 hours after ICU admittance, 24 hours after ICU admittance,
a Swan-Ganz catheter will be used for hemodynamic measurements
change from baseline in systemic vascular resistance (SVR)
时间窗: 10 minutes after anesthesia induction, 10 minutes after bypass discontinuation, end of operation (an average period of 3 hours after start of surgery), 12 hours after ICU admittance, 24 hours after ICU admittance,
a Swan-Ganz catheter will be used for hemodynamic measurements
change from baseline in pulmonary capillary wedge pressure (PCWP)
时间窗: 10 minutes after anesthesia induction, 10 minutes after bypass discontinuation, end of operation (an average period of 3 hours after start of surgery),12 hours after ICU admittance, 24 hours after ICU admittance,
a Swan-Ganz catheter will be used for hemodynamic measurements
change from baseline in pulmonary vascular resistance (PVR)
时间窗: 10 minutes after anesthesia induction, 10 minutes after bypass discontinuation, end of operation (an average period of 3 hours after start of surgery), 12 hours after ICU admittance, 24 hours after ICU admittance,
a Swan-Ganz catheter will be used for hemodynamic measurements
change from baseline in cardiac function
时间窗: 10 minutes after anesthesia induction, 10 minutes after bypass discontinuation, end of operation (an average period of 3 hours after start of surgery)
transesophageal echocardiography will be used for echocardiographic measurements
次要结局
未报告次要终点
研究者
Dr Kassiani Theodoraki
Professor of Anesthesiology
Aretaieion University Hospital