The present pilot study aims to investigate the effectiveness of the preoperative infusion of levosimendan in patients with impaired left ventricular function undergoing coronary artery bypass grafting.
Myocardial revascularization in patients with impaired left ventricular function remains a serious problem in cardiac surgery. Despite the recent developments with the use of new surgical techniques (mini-extracorporeal circulation, off pump surgery) the perioperative morbidity and mortality are relatively high. Therapeutic solutions with the use of inotropic drugs, as adrenergic agonists and phosphodiesterase inhibitors, have offered important improvement to the hemodynamic status of these patients, but they have not considerably decreased mortality. These drugs owe their positive inotropic action to the increase of intracellular calcium and thereafter they improve the myocardial function. Levosimendan (SIMDAX) is a new calcium sensitizer which increases the myocardial contractility without particular promotion of the intracellular calcium accumulation. Contemporary experimental and clinical data demonstrated the effectiveness of this drug in the reduction of surgical mortality to the patients with low left ventricular ejection fraction (LVEF) who undergo coronary artery bypass grafting (CABG). This is an original prospective randomized controlled study focused on the preoperative use of this drug in patients with impaired left ventricular function which is associated with a high operative risk (i.e. EuroSCORE). Perioperative myocardial stunning is particularly evident in this cohort of patients. Prophylactic administration of levosimendan the day before the operation could be translated in improved myocardial performance intraoperatively and during the early postoperative period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
32
Prophylactic 24h infusion of levosimendan at a dose of 0.1 mg/kg/min
Twenty-four hour administration of placebo
Department of Cardiothoracic Surgery, AHEPA University Hospital
Thessaloniki, Greece
Left ventricular function
Left ventricular function as assessed by transthoracic or transesophageal echocardiography on the seventh postoperative day
Time frame: Seventh postoperative day
Perioperative mortality
Time frame: 30 days postoperatively
Need for intraaortic balloon pump
Time frame: 1st-7th postoperative day
Inotropic support
Need for high inotropic support
Time frame: 1st-7th postoperative day
Total ICU stay
Time frame: 1st-7th postoperative day
Total length of hospital stay
Time frame: 1st-7th postoperative day
Time on mechanical ventilation
Time frame: 1st-7th postoperative day
Major adverse cardiovascular events
Perioperative myocardial infarction, stroke, need for revascularization)
Time frame: 1st-7th postoperative day
Morbidity
Time frame: 1st-7th postoperative day
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