Preoperative levosimendán and Hip Fracture

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Study Completion Date

2019-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparing Efficacy of Intravenous Dexmedetomidine and Lidocaine on Postoperative Analgesia in Patients Undergoing Fracture Hip Surgery

NCT06865469

Fracture Hip Surgery

NOT_YET_RECRUITING PHASE3

Regional vs General Anesthesia in Patients With Hip Fracture Under Treatment With Clopidogrel

NCT03596060

Hip Fractures

UNKNOWN NA

Postoperative Analgesia With Local Infiltration After Hip Fracture Of Intertrochanteric Type

NCT01119209

Hip Fracture of Intertrochanteric Type

COMPLETED PHASE4

Traumatologic Acute Pain Management With Fentanyl Transdermal Therapeutic System (TTS)

NCT04026022

Hip Fractures (ICD-10 72.01-72.2)

COMPLETED PHASE3

Oxycodone Versus Intravenous Morphine for Postoperative Analgesia After Hip Surgery

NCT01536301

Arthroplasty, Replacement, Hip

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ventricular Dysfunction, Left Hip Fracture

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Levosimendan

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

Levosimendan

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Levosimendan

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Simdax.

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No