Preoperative levosimendán and Hip Fracture

Completed

• Conditions: Hip Fracture; Ventricular Dysfunction, Left
• Interventions: Drug: Levosimendan

• Registration Number: NCT02972918
• Lead Sponsor: Hospital Universitario de Canarias

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.

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2016-11-14
• Study First Submitted QC: 2016-11-21
• Study First Posted: 2016-11-25
• Primary Completion: 2018-09
• Study Completion: 2019-04
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-03
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Levosimendan	Levosimendan	At least 12 hours before surgery: Infusion of levosimendan (0,1 mcg/kg/min). 24 hours of infusion without a bolus.

Primary Outcome Measures

Name	Time	Method
Change in cardiac index	48 hours after start of iv infusion	Measured through arterial pulse wave analysis. A baseline measurement is done before infusion is started
The effects of Levosimendan on left ventricular function.	Baseline and every 24 hours postoperative, 48 h postoperative, and 7 days and after 30 days postoperative.	Changes of left ventricular function as assessed transthoracic.

Secondary Outcome Measures

Name	Time	Method
morbidity	3 months	All cause
Major adverse cardiovascular events	1st-30th postoperative day	Perioperative heart failure infarction, stroke
Time on mechanical ventilation	1st-30th postoperative day	Perioperative heart failure infarction, stroke
Changes in transport and tissue perfusion of oxygen	1 to 2 day postoperative	measured by arterial and venous blood gases
Changes in NT-proBNP and troponin I	24 hours postoperative, 48 h postoperative, 72 h postoperative, and 168 h postoperative	Plasma NT-proBNP levels were measured
Use of high inotropes (dopamine, Norepinephrine)	after 12 hours, after 48 hours and every 24 hours if still in the PO-Unit	during postoperative unit stay.
mortality	measured at 3 months	All cause
Perioperative mortality	7 days postoperative	All cause
Changes in renal function	1 to 7 days postoperative	Proportion of subjects who develop AKIN stage 1 (increase \> 0.3 mg/dl or \> 25% in serum creatinine from previous visit)
Number of patients with adverse.	30 days postoperative	Occurence of nausea/vomiting
Number of patients with adverse event.	30 days postoperative	Occurence of headache

Trial Locations

Locations (1)

Complejo Hospitalario Universitario de Canarias; 🇪🇸 La Laguna, S/C Tenerife, Spain