Hip Fracture, Ventricular Dysfunction, Left
Conditions
Brief summary
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
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.
Interventions
DRUGLevosimendan
24h preoperative infusion of levosimendan (0,1 mcg/Kg/min)
Sponsors
Orion Corporation, Orion Pharma
Hospital Universitario de Canarias
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. Patients due to undergo urgent of hip fracture. 2. Patients with cardiac failure (EF \< 45 %). 3. Decompensated heart failure. 4. Informed consent provided by the patient.
Exclusion criteria
1. \<18 years old 2. Emergency surgery 3. Serious aortic stenosis (\< 1 cm2) 4. Sustained ventricular tachycardia or atrial fibrillation \>140 5. Earlier episodes of torsades depointes 6. Systolic blood pressure \< 85 mmHg 7. Serious kidney failure (GFR \< 30 ml/min) 8. Serious liver failure (known class C Child-Pugh score) 9. Allergy levosimendan
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The effects of Levosimendan on left ventricular function. | 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. |
| Change in cardiac index | 48 hours after start of iv infusion | Measured through arterial pulse wave analysis. A baseline measurement is done before infusion is started |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in transport and tissue perfusion of oxygen | 1 to 2 day postoperative | measured by arterial and venous blood gases |
| Changes in renal function | 1 to 7 days postoperative | Proportion of subjects who develop AKIN stage 1 (increase \> 0.3 mg/dl or \> 25% in serum creatinine from previous visit) |
| Changes in NT-proBNP and troponin I | 24 hours postoperative, 48 h postoperative, 72 h postoperative, and 168 h postoperative | Plasma NT-proBNP levels were measured |
| Use of high inotropes (dopamine, Norepinephrine) | after 12 hours, after 48 hours and every 24 hours if still in the PO-Unit | during postoperative unit stay. |
| Number of patients with adverse. | 30 days postoperative | Development of arrhythmias |
| Major adverse cardiovascular events | 1st-30th postoperative day | Perioperative heart failure infarction, stroke |
| Time on mechanical ventilation | 1st-30th postoperative day | Perioperative heart failure infarction, stroke |
| mortality | measured at 3 months | All cause |
| Perioperative mortality | 7 days postoperative | All cause |
| morbidity | 3 months | All cause |
| Number of patients with adverse event. | 30 days postoperative | Occurence of headache |
Countries
Spain
Outcome results
None listed