Esmolol in Cardiac Surgery

Università Vita-Salute San Raffaele200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

200

Conditions

Cardiac Surgery

Interventions

EsmololDRUG

esmolol (1-3 mg/kg) during cardiac surgery

PlaceboDRUG

normosaline (same ml of the study drug)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Vita-Salute University

Milan, Italy

Outcomes

Primary Outcomes

Composite endpoint of number of dead patients and/or number of patients requiring prolonged ICU stay.

Time frame: Hospital stay (approximately 2 weeks)

Secondary Outcomes

Number of patients with ventricular fibrillation after cardiopulmonary bypass

Time frame: 30 days and 1 year

Number of patients with low cardiac output syndrome

Time frame: 30 days and 1 year

Number of patients requiring post-operative inotropic support

Time frame: 30 days and 1 year

peak postoperative cardiac troponin level

Time frame: 30 days and 1 year

Data from ClinicalTrials.gov

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