Preoperative levosimendán and Hip Fracture

Study Overview
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Brief Summary
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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.

Detailed Description
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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. The patients will be selected for more than 24 months.

Official Title
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Preoperative Optimization Levosimendan in Heart Failure Patients Undergoing Hip Fracture

Conditions
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Ventricular Dysfunction, Left, Hip Fracture

Intervention / Treatment
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* Drug: Levosimendan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients due to undergo urgent of hip fracture. Patients with cardiac failure (EF < 45 %). Decompensated heart failure. Informed consent provided by the patient. Exclusion Criteria: <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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Levosimendan<br>At least 12 hours before surgery: Infusion of levosimendan (0,1 mcg/kg/min). 24 hours of infusion without a bolus. | Drug: Levosimendan<br>* 24h preoperative infusion of levosimendan (0,1 mcg/Kg/min)<br>* Other names: Simdax.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effects of Levosimendan on left ventricular function. | Changes of left ventricular function as assessed transthoracic. | Baseline and every 24 hours postoperative, 48 h postoperative, and 7 days and after 30 days postoperative. | 
| Change in cardiac index | Measured through arterial pulse wave analysis. A baseline measurement is done before infusion is started | 48 hours after start of iv infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in transport and tissue perfusion of oxygen | measured by arterial and venous blood gases | 1 to 2 day postoperative | 
| Changes in renal function | Proportion of subjects who develop AKIN stage 1 (increase > 0.3 mg/dl or > 25% in serum creatinine from previous visit) | 1 to 7 days postoperative | 
| Changes in NT-proBNP and troponin I | Plasma NT-proBNP levels were measured | 24 hours postoperative, 48 h postoperative, 72 h postoperative, and 168 h postoperative | 
| Number of patients with adverse. | Development of arrhythmias | 30 days postoperative | 
| Number of patients with adverse. | Occurence of nausea/vomiting | 30 days postoperative | 
| Number of patients with adverse event. | Occurence of headache | 30 days postoperative | 
| Use of high inotropes (dopamine, Norepinephrine) | during postoperative unit stay. | after 12 hours, after 48 hours and every 24 hours if still in the PO-Unit | 
| morbidity | All cause | 3 months | 
| Major adverse cardiovascular events | Perioperative heart failure infarction, stroke | 1st-30th postoperative day | 
| Time on mechanical ventilation | Perioperative heart failure infarction, stroke | 1st-30th postoperative day | 
| mortality | All cause | measured at 3 months | 
| Perioperative mortality | All cause | 7 days postoperative |