Coronary Artery Disease
Conditions
Keywords
coronary artery disease, levosimendan, coronary artery bypass grafting, cardiac surgery
Brief summary
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.
Detailed description
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.
Interventions
DRUGLevosimendan infusion
Prophylactic 24h infusion of levosimendan at a dose of 0.1 mg/kg/min
DRUGPlacebo infusion
Twenty-four hour administration of placebo
Sponsors
Orion Corporation, Orion Pharma
AHEPA University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* coronary artery disease which warrants myocardial revascularization with coronary artery bypass grafting according to current guidelines * age \< 79 years old * left ventricular ejection fraction \<= 40% * informed patient's consent
Exclusion criteria
* age \< 18 years old * emergency surgery * medical history of acute myocardial infarction with ST elevation (STEMI) less than 14 days old * any severe comorbidity which increases the perioperative risk (i.e. neoplasia, rheumatoid arthritis, chronic obstructive pulmonary disease) * need for valvular replacement surgery * redo surgery * serum creatinine \> 2 mg/dl * history of malignant cardiac arrhythmias
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Left ventricular function | Seventh postoperative day | Left ventricular function as assessed by transthoracic or transesophageal echocardiography on the seventh postoperative day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need for intraaortic balloon pump | 1st-7th postoperative day | — |
| Inotropic support | 1st-7th postoperative day | Need for high inotropic support |
| Total ICU stay | 1st-7th postoperative day | — |
| Perioperative mortality | 30 days postoperatively | — |
| Time on mechanical ventilation | 1st-7th postoperative day | — |
| Major adverse cardiovascular events | 1st-7th postoperative day | Perioperative myocardial infarction, stroke, need for revascularization) |
| Morbidity | 1st-7th postoperative day | — |
| Total length of hospital stay | 1st-7th postoperative day | — |
Countries
Greece
Outcome results
None listed