Myocardial Protection With Esmolol in Patients With Hypertrophic Obstructive Cardiomyopathy Undergoing Surgery Under Cardiopulmonary Bypass
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Peak concentration of Troponin I
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Esmolol
1 mg/kg (max. 100 mg) as a bolus before aortic cross-clamping and 2 mg/kg (max. 200 mg) in the cardioplegia solution
Intervention: Esmolol (Drug)
Placebo
Equivalent volume of saline as a bolus before aortic cross-clamping and in the cardioplegic solution
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Peak concentration of Troponin I
Time Frame: From the randomization to the postoperative day 3 (POD 3)
Secondary Outcomes
- The incidence of acute kidney injury(through study completion, an average of 4 weeks)
- Peak serum creatinine concentration(through study completion, an average of 4 weeks)
- The need for (yes/no) inotropic agents(through study completion, an average of 4 weeks)
- The need for (yes/no) defibrillation(through study completion, an average of 4 weeks)
- Left ventricular ejection fraction(through study completion, an average of 4 weeks)
- The incidence of new-onset moderate and severe arrhythmias of cardiac arrest(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)