Esmolol in Cardiac Surgery

Phase 4

Completed

• Conditions: Cardiac Surgery
• Interventions: Drug: Placebo; Drug: Esmolol

• Registration Number: NCT00959569
• Lead Sponsor: Università Vita-Salute San Raffaele

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-13
• Study First Submitted QC: 2009-08-13
• Study First Posted: 2009-08-14
• Primary Completion: 2018-05
• Study Completion: 2018-06
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-09
• Last Update Posted: 2018-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
normosaline	Placebo	normosaline (same ml of the study drug)
esmolol	Esmolol	the study group will receive esmolol (1-3 mg/kg)

Primary Outcome Measures

Name	Time	Method
Composite endpoint of number of dead patients and/or number of patients requiring prolonged ICU stay.	Hospital stay (approximately 2 weeks)

Secondary Outcome Measures

Name	Time	Method
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
peak postoperative cardiac troponin level	30 days and 1 year
Number of patients requiring post-operative inotropic support	30 days and 1 year

Trial Locations

Locations (1)

Vita-Salute University; 🇮🇹 Milano, Italy