Cardiac Surgery
Conditions
Keywords
esmolol, cardiac surgery, cardiac anesthesia, mortality, beta blockers, beta-blockers, cardiac protection
Brief summary
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.
Interventions
DRUGEsmolol
esmolol (1-3 mg/kg) during cardiac surgery
DRUGPlacebo
normosaline (same ml of the study drug)
Sponsors
Università Vita-Salute San Raffaele
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* end diastolic diameter \>60 mm and/or an ejection fraction \<50% * written informed consent * age \>18 years
Exclusion criteria
* previous unusual response to esmolol * inclusion in other randomized studies * esmolol administration in the previous 30 days * emergency operation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite endpoint of number of dead patients and/or number of patients requiring prolonged ICU stay. | Hospital stay (approximately 2 weeks) |
Secondary
| Measure | 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 |
| Number of patients requiring post-operative inotropic support | 30 days and 1 year |
| peak postoperative cardiac troponin level | 30 days and 1 year |
Countries
Italy
Outcome results
None listed