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Perioperative blockage of beta-adrenoreceptors is widely used in cardiac and non-cardiac surgery to reduce the rate of cardiovascular complications. Several randomized-controlled studies and meta-analysis showed that esmolol reduces the incidence of myocardial ischemia and arrhythmias in cardiac surgery as well as enhances postoperative cardiac performance. No studies assessed the influence of esmolol in patients with hypertrophic obstructive cardiomyopathy undergoing cardiac surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Esmolol | Experimental | 1 mg/kg (max. 100 mg) as a bolus before aortic cross-clamping and 2 mg/kg (max. 200 mg) in the cardioplegia solution |
|
| Placebo | Placebo Comparator | Equivalent volume of saline as a bolus before aortic cross-clamping and in the cardioplegic solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esmolol | Drug | Esmolol injected intravenously and added to cardioplegia solution |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Peak concentration of Troponin I | From the randomization to the postoperative day 3 (POD 3) |
| Measure | Description | Time Frame |
|---|---|---|
| The need for (yes/no) inotropic agents | Number of patients requiring inotropic support | through study completion, an average of 4 weeks |
| The need for (yes/no) defibrillation | Number of patients requiring defibrlillation after removal of aortic cross clamp |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vladimir Lomivorotov | Contact | +79139164103 | vvlom@mail.ru | |
| Alexander Bogachev-Prokophiev | Contact | bogachev.prokophiev@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| E. Meshalkin National Medical Research Center | Recruiting | Novosibirsk | Russia |
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| Label | URL |
|---|---|
| Related Info | View source |
| Related Info | View source |
| Related Info |
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| ID | Term |
|---|---|
| D002312 | Cardiomyopathy, Hypertrophic |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001020 | Aortic Stenosis, Subvalvular |
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| ID | Term |
|---|---|
| C036604 | esmolol |
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| Placebo |
| Drug |
Equivalent volume of placebo (saline) as a bolus before aortic cross-clamping and in the cardioplegic solution |
|
| through study completion, an average of 4 weeks |
| The incidence of new-onset moderate and severe arrhythmias of cardiac arrest | Number of patients with arrhythmias | through study completion, an average of 4 weeks |
| Left ventricular ejection fraction | through study completion, an average of 4 weeks |
| Peak serum creatinine concentration | through study completion, an average of 4 weeks |
| The incidence of acute kidney injury | through study completion, an average of 4 weeks |
| Duration of mechanical ventilation | through study completion, an average of 4 weeks |
| Duration of ICU stay | through study completion, an average of 4 weeks |
| Duration of hospital stay | through study completion, an average of 4 weeks |
| 30-day all-cause mortality | through study completion, an average of 4 weeks |
| Presence of diastolic dysfunction | through study completion, an average of 4 weeks |
| The dosage of inotropic agents (inotropic score) | through study completion, an average of 4 weeks |
| D001024 |
| Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |