NCT02972918

Preoperative levosimendán and Hip Fracture

Preoperative Optimization Levosimendan in Heart Failure Patients Undergoing Hip Fracture

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 19 (actual)
• Sponsor: Hospital Universitario de Canarias · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ventricular Dysfunction, Left
• Hip Fracture

Interventions

Type	Name	Description
DRUG	Levosimendan	24h preoperative infusion of levosimendan (0,1 mcg/Kg/min)

Timeline

• Start date: 2014-05-01
• Primary completion: 2018-09-01
• Completion: 2019-04-01
• First posted: 2016-11-25
• Last updated: 2020-02-05

Locations

1 site across 1 country: Spain