Preoperative levosimendán and Hip Fracture

Hospital Universitario de Canarias19 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Ventricular Dysfunction, Left Hip Fracture

Interventions

LevosimendanDRUG

24h preoperative infusion of levosimendan (0,1 mcg/Kg/min)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (1)

Complejo Hospitalario Universitario de Canarias

San Cristóbal de La Laguna, S/C Tenerife, Spain

Outcomes

Primary Outcomes

The effects of Levosimendan on left ventricular function.

Changes of left ventricular function as assessed transthoracic.

Time frame: 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

Time frame: 48 hours after start of iv infusion

Secondary Outcomes

Changes in transport and tissue perfusion of oxygen

measured by arterial and venous blood gases

Time frame: 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)

Time frame: 1 to 7 days postoperative

Changes in NT-proBNP and troponin I

Plasma NT-proBNP levels were measured

Time frame: 24 hours postoperative, 48 h postoperative, 72 h postoperative, and 168 h postoperative

Number of patients with adverse.

Development of arrhythmias

Time frame: 30 days postoperative

Number of patients with adverse.

Occurence of nausea/vomiting

Time frame: 30 days postoperative

Number of patients with adverse event.

Occurence of headache

Data from ClinicalTrials.gov

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