Esmolol in Cardiac Surgery (BREVI)

Università Vita-Salute San Raffaele

Status and phase: Completed; Phase 4

Conditions: Cardiac Surgery

Treatments: Drug: Esmolol; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00959569

GO/URC/ER/mm 459/DG

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

esmolol

Experimental group

Description:

the study group will receive esmolol (1-3 mg/kg)

Treatment:

Drug: Esmolol

normosaline

Placebo Comparator group

Description:

normosaline (same ml of the study drug)

Treatment:

Drug: Placebo