Esmolol in Cardiac Surgery (BREVI)

This study is currently recruiting participants.
Verified April 2014 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: April 4, 2014
Last verified: April 2014
  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:


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 2014
Estimated Primary Completion Date: December 2014 (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:
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: April 4, 2014
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 April 22, 2014