Preoperative levosimendán and Hip Fracture (OPL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02972918
Recruitment Status : Recruiting
First Posted : November 25, 2016
Last Update Posted : September 25, 2017
Orion Corporation, Orion Pharma
Information provided by (Responsible Party):
María del Carmen Martín Lorenzo, 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.

Condition or disease Intervention/treatment Phase
Ventricular Dysfunction, Left Hip Fracture Drug: Levosimendan Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Preoperative Optimization Levosimendan in Heart Failure Patients Undergoing Hip Fracture
Actual Study Start Date : May 2014
Actual Primary Completion Date : September 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
At least 12 hours before surgery: Infusion of levosimendan (0,1 mcg/kg/min). 24 hours of infusion without a bolus.
Drug: Levosimendan
24h preoperative infusion of levosimendan (0,1 mcg/Kg/min)
Other Name: Simdax.

Primary Outcome Measures :
  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 Outcome Measures :
  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

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02972918

Contact: Martín Lorenzo, MD
Contact: Jorge Solera Marín, MD

Complejo Hospitalario Universitario de Canarias Recruiting
La Laguna, S/c Tenerife, Spain, 38320
Contact: Magali González-Colaço Harmand, MD, PhD    +34 922675557   
Contact: ANA ALDEA, MD, PhD    +34922678115   
Principal Investigator: María del Carmen Martín Lorenzo, MD         
Sponsors and Collaborators
Hospital Universitario de Canarias
Orion Corporation, Orion Pharma
Principal Investigator: María del Carmen Martín Lorenzo, MD Hospital Universitario de Canarias

Publications of Results:
Responsible Party: María del Carmen Martín Lorenzo, Dr, Hospital Universitario de Canarias Identifier: NCT02972918     History of Changes
Other Study ID Numbers: MML-LEV-2013-01
First Posted: November 25, 2016    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Ventricular Dysfunction
Ventricular Dysfunction, Left
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries
Heart Diseases
Cardiovascular Diseases
Anti-Arrhythmia Agents
Cardiotonic Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Protective Agents
Physiological Effects of Drugs