Skip to main content
OpenTrials
Completed

NCT Number: NCT02972918

Preoperative levosimendán and Hip Fracture

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Complejo Hospitalario Universitario de Canarias

San Cristóbal de La Laguna, S/C Tenerife, 38320, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients due to undergo urgent of hip fracture.
  • Patients with cardiac failure (EF < 45 %).
  • Decompensated heart failure.
  • Informed consent provided by the patient.

Exclusion criteria

  • <18 years old
  • Emergency surgery
  • Serious aortic stenosis (< 1 cm2)
  • Sustained ventricular tachycardia or atrial fibrillation >140
  • Earlier episodes of "torsades depointes"
  • Systolic blood pressure < 85 mmHg
  • Serious kidney failure (GFR < 30 ml/min)
  • Serious liver failure (known class C Child-Pugh score)
  • Allergy levosimendan

Treatment and study plan

Levosimendan

Drug

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

Other names: Simdax.

Primary outcomes

  1. The effects of Levosimendan on left ventricular function.

    Time frame: 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.

  2. Change in cardiac index

    Time frame: 48 hours after start of iv infusion

    Measured through arterial pulse wave analysis. A baseline measurement is done before infusion is started

Secondary outcomes

  1. Changes in transport and tissue perfusion of oxygen

    Time frame: 1 to 2 day postoperative

    measured by arterial and venous blood gases

  2. Changes in renal function

    Time frame: 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)

  3. Changes in NT-proBNP and troponin I

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

    Plasma NT-proBNP levels were measured

  4. Number of patients with adverse.

    Time frame: 30 days postoperative

    Development of arrhythmias

  5. Number of patients with adverse.

    Time frame: 30 days postoperative

    Occurence of nausea/vomiting

  6. Number of patients with adverse event.

    Time frame: 30 days postoperative

    Occurence of headache

  7. Use of high inotropes (dopamine, Norepinephrine)

    Time frame: after 12 hours, after 48 hours and every 24 hours if still in the PO-Unit

    during postoperative unit stay.

  8. morbidity

    Time frame: 3 months

    All cause

  9. Major adverse cardiovascular events

    Time frame: 1st-30th postoperative day

    Perioperative heart failure infarction, stroke

  10. Time on mechanical ventilation

    Time frame: 1st-30th postoperative day

    Perioperative heart failure infarction, stroke

  11. mortality

    Time frame: measured at 3 months

    All cause

  12. Perioperative mortality

    Time frame: 7 days postoperative

    All cause

Sponsors and collaborators

Lead sponsor

Hospital Universitario de Canarias

Other

Collaborators

  • Orion Corporation, Orion Pharma

Registry information

Official study title

Preoperative Optimization Levosimendan in Heart Failure Patients Undergoing Hip Fracture

Acronym: OPL

Important dates

Study start
2014
Primary completion
2018
Study completion
2019
First posted
Nov 25, 2016
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.