Preoperative levosimendán and Hip Fracture
Condition: Ventricular Dysfunction, Left; Hip Fracture
MeSH terms: Ventricular Dysfunction; Ventricular Dysfunction, Left; Fractures, Bone; Hip Fractures
Study type: Observational

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.
    

Intervention name(s): Levosimendan
Intervention type(s): Drug
Intervention description(s): 24h preoperative infusion of levosimendan (0,1 mcg/Kg/min)
Other intervention name(s): Simdax.
Intervention MeSH terms: Simendan
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All the patients with chronic heart failure of any etiology with hip fracture that present
        an acute descompendation of their chronic heart failure and need inotropes because of the
        conventional treatment is not enough