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| Name | Class |
|---|---|
| Orion Corporation, Orion Pharma | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levosimendan | At least 12 hours before surgery: Infusion of levosimendan (0,1 mcg/kg/min). 24 hours of infusion without a bolus. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levosimendan | Drug | 24h preoperative infusion of levosimendan (0,1 mcg/Kg/min) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The effects of Levosimendan on left ventricular function. | Changes of left ventricular function as assessed transthoracic. | 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 | 48 hours after start of iv infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in transport and tissue perfusion of oxygen | measured by arterial and venous blood gases | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| MarÃa del Carmen MartÃn Lorenzo, MD | Hospital Universitario de Canarias | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complejo Hospitalario Universitario de Canarias | San Cristóbal de La Laguna | S/C Tenerife | 38320 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11069188 | Result | 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. | |
| 10093980 | Result | 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. |
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| ID | Term |
|---|---|
| D018487 | Ventricular Dysfunction, Left |
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D018754 | Ventricular Dysfunction |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D005264 | Femoral Fractures |
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| ID | Term |
|---|---|
| D000077464 | Simendan |
| ID | Term |
|---|---|
| D006835 | Hydrazones |
| D006834 | Hydrazines |
| D009930 | Organic Chemicals |
| D011724 | Pyridazines |
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| 1 to 7 days postoperative |
| Changes in NT-proBNP and troponin I | Plasma NT-proBNP levels were measured | 24 hours postoperative, 48 h postoperative, 72 h postoperative, and 168 h postoperative |
| Number of patients with adverse. | Development of arrhythmias | 30 days postoperative |
| Number of patients with adverse. | Occurence of nausea/vomiting | 30 days postoperative |
| Number of patients with adverse event. | Occurence of headache | 30 days postoperative |
| Use of high inotropes (dopamine, Norepinephrine) | during postoperative unit stay. | after 12 hours, after 48 hours and every 24 hours if still in the PO-Unit |
| morbidity | All cause | 3 months |
| Major adverse cardiovascular events | Perioperative heart failure infarction, stroke | 1st-30th postoperative day |
| Time on mechanical ventilation | Perioperative heart failure infarction, stroke | 1st-30th postoperative day |
| mortality | All cause | measured at 3 months |
| Perioperative mortality | All cause | 7 days postoperative |
| 19054201 | Result | 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. |
| 18405408 | Result | 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. |
| D050723 |
| Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |