Esmolol in Cardiac Surgery

Cardiac Surgery Clinical Trial

— BREVI  

Official title:

Esmolol in Cardiac Surgery. A Randomized Controlled Trial With Clinical

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00959569
• Other study ID #: GO/URC/ER/mm 459/DG
• Status: Completed
• Phase: Phase 4
• Start date: August 2009
• Est. completion date: June 2018

Study information

• Verified date: October 2018
• Source: Università Vita-Salute San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Surgery

Intervention

Drug:
• Esmolol
esmolol (1-3 mg/kg) during cardiac surgery
• Placebo
normosaline (same ml of the study drug)

Locations

Country	Name	City	State
Italy	Vita-Salute University	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Università Vita-Salute San Raffaele

Country where clinical trial is conducted

Italy, 

References & Publications (4)

Crescenzi G, Landoni G, Zangrillo A, Guarracino F, Rosica C, La Canna G, Alfieri O. Management and decision-making strategy for systolic anterior motion after mitral valve repair. J Thorac Cardiovasc Surg. 2009 Feb;137(2):320-5. doi: 10.1016/j.jtcvs.2008.08.018. — View Citation

Crescenzi G, Rosica C, Marino G, Serini SM, Covello RD, Landoni G, Zangrillo A. The use of esmolol to treat systolic anterior motion of the mitral valve after mitral valve repair. Eur J Anaesthesiol. 2008 Apr;25(4):342-3. doi: 10.1017/S0265021507002876. — View Citation

Landoni G, Zambon M, Zangrillo A. Reducing perioperative myocardial infarction with anesthetic drugs and techniques. Curr Drug Targets. 2009 Sep;10(9):858-62. Epub 2009 Sep 1. Review. — View Citation

Zangrillo A, Turi S, Crescenzi G, Oriani A, Distaso F, Monaco F, Bignami E, Landoni G. Esmolol reduces perioperative ischemia in cardiac surgery: a meta-analysis of randomized controlled studies. J Cardiothorac Vasc Anesth. 2009 Oct;23(5):625-32. doi: 10.1053/j.jvca.2009.01.003. Epub 2009 Mar 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite endpoint of number of dead patients and/or number of patients requiring prolonged ICU stay.		Hospital stay (approximately 2 weeks)
Secondary	Number of patients with ventricular fibrillation after cardiopulmonary bypass		30 days and 1 year
Secondary	Number of patients with low cardiac output syndrome		30 days and 1 year
Secondary	Number of patients requiring post-operative inotropic support		30 days and 1 year
Secondary	peak postoperative cardiac troponin level		30 days and 1 year