Clinical trial NCT02972918: Preoperative levosimendán and Hip Fracture
Official title: Preoperative Optimization Levosimendan in Heart Failure Patients Undergoing Hip Fracture
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventricular Dysfunction, Left
Hip Fracture
Lead sponsor: Hospital Universitario de Canarias
Sponsor class: OTHER
Collaborators: name: Orion Corporation, Orion Pharma
First posted: 2016-11-25
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: The effects of Levosimendan on left ventricular function.
timeFrame: Baseline and every 24 hours postoperative, 48 h postoperative, and 7 days and after 30 days postoperative.
measure: Change in cardiac index
timeFrame: 48 hours after start of iv infusion
Secondary outcomes:
measure: Changes in transport and tissue perfusion of oxygen
timeFrame: 1 to 2 day postoperative
measure: Changes in renal function
timeFrame: 1 to 7 days postoperative
measure: Changes in NT-proBNP and troponin I
timeFrame: 24 hours postoperative, 48 h postoperative, 72 h postoperative, and 168 h postoperative
measure: Number of patients with adverse.
timeFrame: 30 days postoperative
measure: Number of patients with adverse.
timeFrame: 30 days postoperative
measure: Number of patients with adverse event.
timeFrame: 30 days postoperative
measure: Use of high inotropes (dopamine, Norepinephrine)
timeFrame: after 12 hours, after 48 hours and every 24 hours if still in the PO-Unit
measure: morbidity
timeFrame: 3 months
measure: Major adverse cardiovascular events
timeFrame: 1st-30th postoperative day
measure: Time on mechanical ventilation
timeFrame: 1st-30th postoperative day
measure: mortality
timeFrame: measured at 3 months
measure: Perioperative mortality
timeFrame: 7 days postoperative
Other outcomes:
Locations:
city: La Laguna
country: Spain
facility: Complejo Hospitalario Universitario de Canarias
state: S/C Tenerife
Study officials:
affiliation: Hospital Universitario de Canarias
name: María del Carmen Martín Lorenzo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cauley JA, Thompson DE, Ensrud KC, Scott JC, Black D. Risk of mortality following clinical fractures. Osteoporos Int. 2000;11(7):556-61. doi: 10.1007/s001980070075.
citation: Center JR, Nguyen TV, Schneider D, Sambrook PN, Eisman JA. Mortality after all major types of osteoporotic fracture in men and women: an observational study. Lancet. 1999 Mar 13;353(9156):878-82. doi: 10.1016/S0140-6736(98)09075-8.
citation: Pedersen SJ, Borgbjerg FM, Schousboe B, Pedersen BD, Jorgensen HL, Duus BR, Lauritzen JB; Hip Fracture Group of Bispebjerg Hospital. A comprehensive hip fracture program reduces complication rates and mortality. J Am Geriatr Soc. 2008 Oct;56(10):1831-8. doi: 10.1111/j.1532-5415.2008.01945.x.
citation: Ponschab M, Hochmair N, Ghazwinian N, Mueller T, Plochl W. Levosimendan infusion improves haemodynamics in elderly heart failure patients undergoing urgent hip fracture repair. Eur J Anaesthesiol. 2008 Aug;25(8):627-33. doi: 10.1017/S0265021508004080. Epub 2008 Apr 11.