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| Name | Class |
|---|---|
| Orion Corporation, Orion Pharma | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levosimendan | Active Comparator | Patients treated with prophylactic administration of levosimendan |
|
| Placebo group | Placebo Comparator | Patients managed with placebo administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levosimendan infusion | Drug | Prophylactic 24h infusion of levosimendan at a dose of 0.1 mg/kg/min |
|
| Measure | Description | Time Frame |
|---|---|---|
| Left ventricular function | Left ventricular function as assessed by transthoracic or transesophageal echocardiography on the seventh postoperative day | Seventh postoperative day |
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative mortality | 30 days postoperatively | |
| Need for intraaortic balloon pump | 1st-7th postoperative day | |
| Inotropic support |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyriakos Anastasiadis, MD, FETCS | AHEPA University Hospital | Principal Investigator |
| Christos Papakonstantinou, MD | AHEPA University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiothoracic Surgery, AHEPA University Hospital | Thessaloniki | 546 36 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17377079 | Background | De Hert SG, Lorsomradee S, Cromheecke S, Van der Linden PJ. The effects of levosimendan in cardiac surgery patients with poor left ventricular function. Anesth Analg. 2007 Apr;104(4):766-73. doi: 10.1213/01.ane.0000256863.92050.d3. | |
| 17702589 | Background | Tasouli A, Papadopoulos K, Antoniou T, Kriaras I, Stavridis G, Degiannis D, Geroulanos S. Efficacy and safety of perioperative infusion of levosimendan in patients with compromised cardiac function undergoing open-heart surgery: importance of early use. Eur J Cardiothorac Surg. 2007 Oct;32(4):629-33. doi: 10.1016/j.ejcts.2007.07.010. Epub 2007 Aug 15. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Placebo infusion | Drug | Twenty-four hour administration of placebo |
|
Need for high inotropic support |
| 1st-7th postoperative day |
| Total ICU stay | 1st-7th postoperative day |
| Total length of hospital stay | 1st-7th postoperative day |
| Time on mechanical ventilation | 1st-7th postoperative day |
| Major adverse cardiovascular events | Perioperative myocardial infarction, stroke, need for revascularization) | 1st-7th postoperative day |
| Morbidity | 1st-7th postoperative day |
| 19592266 | Background | Kolseth SM, Nordhaug DO, Stenseth R, Sellevold O, Kirkeby-Garstad I, Wahba A. Prophylactic treatment with levosimendan: a retrospective matched-control study of patients with reduced left ventricular function. Eur J Cardiothorac Surg. 2009 Dec;36(6):1024-30. doi: 10.1016/j.ejcts.2009.05.001. Epub 2009 Jul 9. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |