Hypertrophic Obstructive Cardiomyopathy
Conditions
Brief summary
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.
Interventions
DRUGEsmolol
Esmolol injected intravenously and added to cardioplegia solution
DRUGPlacebo
Equivalent volume of placebo (saline) as a bolus before aortic cross-clamping and in the cardioplegic solution
Sponsors
Meshalkin Research Institute of Pathology of Circulation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years * Signed informed consent * Patient with hypertrophic obstructive cardiomyopathy undergoing surgery under cardiopulmonary bypass
Exclusion criteria
* History of adverse effects on esmolol * Urgent/emergent surgery * Administration of esmolol in 30 days before randomization * Participation in other randomized trial during same hospitalization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak concentration of Troponin I | From the randomization to the postoperative day 3 (POD 3) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The need for (yes/no) inotropic agents | through study completion, an average of 4 weeks | Number of patients requiring inotropic support |
| The need for (yes/no) defibrillation | through study completion, an average of 4 weeks | Number of patients requiring defibrlillation after removal of aortic cross clamp |
| The incidence of new-onset moderate and severe arrhythmias of cardiac arrest | through study completion, an average of 4 weeks | Number of patients with arrhythmias |
| 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 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 | — |
| Duration of mechanical ventilation | through study completion, an average of 4 weeks | — |
Countries
Russia
Contacts
Primary ContactVladimir Lomivorotov
Backup ContactAlexander Bogachev-Prokophiev
Outcome results
None listed