Preoperative levosimendán and Hip Fracture

Hip Fracture Clinical Trial

— OPL  

Official title:

Preoperative Optimization Levosimendan in Heart Failure Patients Undergoing Hip Fracture

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02972918
• Other study ID #: MML-LEV-2013-01
• Status: Completed
• Start date: May 2014
• Est. completion date: April 2019

Study information

• Verified date: February 2020
• Source: Hospital Universitario de Canarias
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: April 2019
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fracture
• Hip Fractures
• Ventricular Dysfunction
• Ventricular Dysfunction, Left

Intervention

Drug:
• Levosimendan
24h preoperative infusion of levosimendan (0,1 mcg/Kg/min)

Locations

Country	Name	City	State
Spain	Complejo Hospitalario Universitario de Canarias	La Laguna	S/C Tenerife

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitario de Canarias	Orion Corporation, Orion Pharma

Country where clinical trial is conducted

Spain, 

References & Publications (4)

Cauley JA, Thompson DE, Ensrud KC, Scott JC, Black D. Risk of mortality following clinical fractures. Osteoporos Int. 2000;11(7):556-61. — View 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. — View Citation

Pedersen SJ, Borgbjerg FM, Schousboe B, Pedersen BD, Jørgensen 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. d — View Citation

Ponschab M, Hochmair N, Ghazwinian N, Mueller T, Plöchl 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. Epu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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
Secondary	Changes in transport and tissue perfusion of oxygen	measured by arterial and venous blood gases	1 to 2 day postoperative
Secondary	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)	1 to 7 days postoperative
Secondary	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
Secondary	Number of patients with adverse.	Development of arrhythmias	30 days postoperative
Secondary	Number of patients with adverse.	Occurence of nausea/vomiting	30 days postoperative
Secondary	Number of patients with adverse event.	Occurence of headache	30 days postoperative
Secondary	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
Secondary	morbidity	All cause	3 months
Secondary	Major adverse cardiovascular events	Perioperative heart failure infarction, stroke	1st-30th postoperative day
Secondary	Time on mechanical ventilation	Perioperative heart failure infarction, stroke	1st-30th postoperative day
Secondary	mortality	All cause	measured at 3 months
Secondary	Perioperative mortality	All cause	7 days postoperative