Preoperative Optimization Levosimendan in Heart Failure Patients Undergoing Hip Fracture
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Change in cardiac index
研究概览
简要总结
The purpose of this study is to evaluate whether preoperative optimization with levosimendan in heart failure patients undergoing hip fracture surgery improves haemodynamic and tissue perfusion parameters.
详细描述
Hip fracture is a very predominant entity in elderly patients and it is one of the most frequent cause of admission in a hospital.
Elderly patients undergoing surgery for hip fracture have a high risk of morbidity and mortality in the postoperative. Several studies have shown that there is a high risk of cardiovascular complications in this group of patients and 3-months mortality is 15-20%. One of the causes of this high morbidity and mortality is the high incidence of chronic cardiac failure in this patients. The goal of the present study is to evaluate if the optimization of preoperative cardiac function with levosimendan in patients with left ventricular ejection fraction < 45% can improve haemodynamic and the tissue perfusion values, and reduce cardiac morbidity and mortality 3 months postoperatively.
Following written consent, the patients with left ventricular ejection fraction < 45% will be admitted in the resuscitation and anaesthesia room where they will receive a levosimendan intravenous injection undergoing a strict haemodynamic vigilance.
Before the levosimendan intravenous injection the patients firs have an echocardiography to evaluate myocardial function, NT-proBNP. Subsequently, an arterial line is inserted and optimization achieved by using this arterial line connected to a ProAQT sensor system ( PULSION , Edwards). The system uses pulse wave analysis to assess several parameters including: stroke volume index (SVI), cardiac index (CI), systemic vascular resistance index (SVRI), cardiac power index (CPI).The levosimendan will be administered like a continues injection during 24 hours (0,1 mcg/kg/min) without initial dose. Following the optimization the patients will be transferred to the operating room in the next 3 days and will come back to the resuscitation and anaesthesia room where they will stay 24 hours more if there is no any complication.
All the cardiac complications will be documented and follw-up will be done by after 30 days and 3 months postoperative.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients due to undergo urgent of hip fracture.
- •Patients with cardiac failure (EF < 45 %).
- •Decompensated heart failure.
- •Informed consent provided by the patient.
排除标准
- •<18 years old
- •Emergency surgery
- •Serious aortic stenosis (< 1 cm2)
- •Sustained ventricular tachycardia or atrial fibrillation >140
- •Earlier episodes of "torsades depointes"
- •Systolic blood pressure < 85 mmHg
- •Serious kidney failure (GFR < 30 ml/min)
- •Serious liver failure (known class C Child-Pugh score)
- •Allergy levosimendan
研究组 & 干预措施
Levosimendan
At least 12 hours before surgery: Infusion of levosimendan (0,1 mcg/kg/min). 24 hours of infusion without a bolus.
干预措施: Levosimendan (Drug)
结局指标
主要结局
Change in cardiac index
时间窗: 48 hours after start of iv infusion
Measured through arterial pulse wave analysis. A baseline measurement is done before infusion is started
The effects of Levosimendan on left ventricular function.
时间窗: Baseline and every 24 hours postoperative, 48 h postoperative, and 7 days and after 30 days postoperative.
Changes of left ventricular function as assessed transthoracic.
次要结局
- Changes in NT-proBNP and troponin I(24 hours postoperative, 48 h postoperative, 72 h postoperative, and 168 h postoperative)
- morbidity(3 months)
- Major adverse cardiovascular events(1st-30th postoperative day)
- Time on mechanical ventilation(1st-30th postoperative day)
- Changes in transport and tissue perfusion of oxygen(1 to 2 day postoperative)
- Use of high inotropes (dopamine, Norepinephrine)(after 12 hours, after 48 hours and every 24 hours if still in the PO-Unit)
- mortality(measured at 3 months)
- Perioperative mortality(7 days postoperative)
- Changes in renal function(1 to 7 days postoperative)
- Number of patients with adverse.(30 days postoperative)
- Number of patients with adverse event.(30 days postoperative)
研究者
María del Carmen Martín Lorenzo
Dr
Hospital Universitario de Canarias