Prophylactic Administration of Levosimendan in Patients Undergoing Coronary Surgery
- Conditions
- Coronary Artery Disease
- Interventions
- Drug: Placebo infusion
- Registration Number
- NCT01318460
- Lead Sponsor
- AHEPA University Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Levosimendan Levosimendan infusion Patients treated with prophylactic administration of levosimendan Placebo group Placebo infusion Patients managed with placebo administration
- Primary Outcome Measures
Name Time Method Left ventricular function Seventh postoperative day Left ventricular function as assessed by transthoracic or transesophageal echocardiography on the seventh postoperative day
- Secondary Outcome Measures
Name Time Method Total ICU stay 1st-7th postoperative day Morbidity 1st-7th postoperative day Perioperative mortality 30 days postoperatively Inotropic support 1st-7th postoperative day Need for high inotropic support
Time on mechanical ventilation 1st-7th postoperative day Need for intraaortic balloon pump 1st-7th postoperative day Total length of hospital stay 1st-7th postoperative day Major adverse cardiovascular events 1st-7th postoperative day Perioperative myocardial infarction, stroke, need for revascularization)
Trial Locations
- Locations (1)
Department of Cardiothoracic Surgery, AHEPA University Hospital
🇬🇷Thessaloniki, Greece