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This large randomized double-blind clinical trial (esmolol vs placebo) will enroll patients undergoing cardiac surgery to study the additive cardiac protection of this therapeutic strategy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| esmolol | Experimental | the study group will receive esmolol (1-3 mg/kg) |
|
| normosaline | Placebo Comparator | normosaline (same ml of the study drug) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esmolol | Drug | esmolol (1-3 mg/kg) during cardiac surgery |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite endpoint of number of dead patients and/or number of patients requiring prolonged ICU stay. | Hospital stay (approximately 2 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with ventricular fibrillation after cardiopulmonary bypass | 30 days and 1 year | |
| Number of patients with low cardiac output syndrome | 30 days and 1 year | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vita-Salute University | Milan | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19297196 | Background | Zangrillo A, Turi S, Crescenzi G, Oriani A, Distaso F, Monaco F, Bignami E, Landoni G. Esmolol reduces perioperative ischemia in cardiac surgery: a meta-analysis of randomized controlled studies. J Cardiothorac Vasc Anesth. 2009 Oct;23(5):625-32. doi: 10.1053/j.jvca.2009.01.003. Epub 2009 Mar 18. | |
| 18334040 | Background |
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| ID | Term |
|---|---|
| C036604 | esmolol |
| D000319 | Adrenergic beta-Antagonists |
| ID | Term |
|---|---|
| D018674 | Adrenergic Antagonists |
| D018663 | Adrenergic Agents |
| D018377 | Neurotransmitter Agents |
| D045504 | Molecular Mechanisms of Pharmacological Action |
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| Placebo | Drug | normosaline (same ml of the study drug) |
|
| Number of patients requiring post-operative inotropic support |
| 30 days and 1 year |
| peak postoperative cardiac troponin level | 30 days and 1 year |
| Crescenzi G, Rosica C, Marino G, Serini SM, Covello RD, Landoni G, Zangrillo A. The use of esmolol to treat systolic anterior motion of the mitral valve after mitral valve repair. Eur J Anaesthesiol. 2008 Apr;25(4):342-3. doi: 10.1017/S0265021507002876. No abstract available. |
| 19538174 | Background | Landoni G, Zambon M, Zangrillo A. Reducing perioperative myocardial infarction with anesthetic drugs and techniques. Curr Drug Targets. 2009 Sep;10(9):858-62. doi: 10.2174/138945009789108837. Epub 2009 Sep 1. |
| 19185145 | Background | Crescenzi G, Landoni G, Zangrillo A, Guarracino F, Rosica C, La Canna G, Alfieri O. Management and decision-making strategy for systolic anterior motion after mitral valve repair. J Thorac Cardiovasc Surg. 2009 Feb;137(2):320-5. doi: 10.1016/j.jtcvs.2008.08.018. |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045505 | Physiological Effects of Drugs |