Esmolol in Cardiac Surgery (BREVI)

This study is currently recruiting participants.

Verified October 2012 by Università Vita-Salute San Raffaele

Sponsor:

Information provided by:

Università Vita-Salute San Raffaele

ClinicalTrials.gov Identifier:

NCT00959569

First received: August 13, 2009

Last updated: October 11, 2012

Last verified: October 2012

History of Changes

Purpose

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.

Condition	Intervention	Phase
Cardiac Surgery	Drug: Esmolol Drug: Placebo	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Esmolol in Cardiac Surgery. A Randomized Controlled Trial With Clinical

Resource links provided by NLM:

MedlinePlus related topics: Heart Surgery

Drug Information available for: Esmolol hydrochloride

U.S. FDA Resources

Further study details as provided by Università Vita-Salute San Raffaele:

Primary Outcome Measures:

Composite endpoint or number of dead patients and/or number of patients requiring prolonged ICU stay. [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of patients with ventricular fibrillation after cardiopulmonary bypass [ Designated as safety issue: No ]
Number of patients with low cardiac output syndrome
Number of patients requiring post-operative inotropic support
peak postoperative cardiac troponin level

Estimated Enrollment:	200
Study Start Date:	August 2009
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: esmolol the study group will receive esmolol (1-3 mg/kg)	Drug: Esmolol esmolol (1-3 mg/kg) during cardiac surgery Other Name: Beta-blocker; Beta blocker; breviblock
Placebo Comparator: normosaline normosaline (same ml of the study drug)	Drug: Placebo normosaline (same ml of the study drug)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

end diastolic diameter >60 mm and 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00959569

Contacts

Contact: giovanni landoni, MD		landoni.giovanni@hsr.it
Contact: elena bignami, MD		bignami.elena@hsr.it

Locations

Italy
Vita-Salute University	Recruiting
Milano, Italy
Contact: giovanni landoni, MD landoni.giovanni@hsr.it
Contact: elena bignami, MD bignami.elena@hsr.it

Sponsors and Collaborators

Università Vita-Salute San Raffaele

More Information

Publications:

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 Mar 17; [Epub ahead of print]

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. No abstract available.

Landoni G, Zambon M, Zangrillo A. Reducing Perioperative Myocardial Infarction with Anesthetic Drugs and Techniques. Curr Drug Targets. 2009 Sep 1; [Epub ahead of print]

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.

Responsible Party:	Landoni Giovanni, Vita-Salute University of Milano, Italy
ClinicalTrials.gov Identifier:	NCT00959569 History of Changes
Other Study ID Numbers:	GO/URC/ER/mm 459/DG
Study First Received:	August 13, 2009
Last Updated:	October 11, 2012
Health Authority:	Italy: Ministry of Health

Keywords provided by Università Vita-Salute San Raffaele:

esmolol
cardiac surgery
cardiac anesthesia
mortality

beta blockers
beta-blockers
cardiac protection

Additional relevant MeSH terms:

Adrenergic beta-Antagonists
Esmolol
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists

ClinicalTrials.gov processed this record on May 19, 2013

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