Complejo Hospitalario Universitario de Canarias
San Cristóbal de La Laguna, S/C Tenerife, 38320, Spain
NCT Number: NCT02972918
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.
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Notify Me18 year–100 year
All sexes
Observational
San Cristóbal de La Laguna, S/C Tenerife, 38320, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
24h preoperative infusion of levosimendan (0,1 mcg/Kg/min)
Other names: Simdax.
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.
Time frame: 48 hours after start of iv infusion
Measured through arterial pulse wave analysis. A baseline measurement is done before infusion is started
Time frame: 1 to 2 day postoperative
measured by arterial and venous blood gases
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)
Time frame: 24 hours postoperative, 48 h postoperative, 72 h postoperative, and 168 h postoperative
Plasma NT-proBNP levels were measured
Time frame: 30 days postoperative
Development of arrhythmias
Time frame: 30 days postoperative
Occurence of nausea/vomiting
Time frame: 30 days postoperative
Occurence of headache
Time frame: after 12 hours, after 48 hours and every 24 hours if still in the PO-Unit
during postoperative unit stay.
Time frame: 3 months
All cause
Time frame: 1st-30th postoperative day
Perioperative heart failure infarction, stroke
Time frame: 1st-30th postoperative day
Perioperative heart failure infarction, stroke
Time frame: measured at 3 months
All cause
Time frame: 7 days postoperative
All cause
Hospital Universitario de Canarias
Other
Preoperative Optimization Levosimendan in Heart Failure Patients Undergoing Hip Fracture
Acronym: OPL
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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.
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