Esmolol in Cardiac Surgery (BREVI)

This study is currently recruiting participants. (see Contacts and Locations)
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

August 13, 2009
April 4, 2014
August 2009
December 2014   (final data collection date for primary outcome measure)
Composite endpoint or number of dead patients and/or number of patients requiring prolonged ICU stay. [ Designated as safety issue: No ]
Reduce prolonged ICU stay / mortality [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00959569 on ClinicalTrials.gov Archive Site
  • 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
--ventricular fibrillation after cardiopulmonary bypass --low cardiac output syndrome --need for inotropic support --peak postoperative cardiac troponin level [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Esmolol in Cardiac Surgery
Esmolol in Cardiac Surgery. A Randomized Controlled Trial With Clinical

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Cardiac Surgery
  • Drug: Esmolol
    esmolol (1-3 mg/kg) during cardiac surgery
    Other Name: Beta-blocker; Beta blocker; breviblock
  • Drug: Placebo
    normosaline (same ml of the study drug)
  • Experimental: esmolol
    the study group will receive esmolol (1-3 mg/kg)
    Intervention: Drug: Esmolol
  • Placebo Comparator: normosaline
    normosaline (same ml of the study drug)
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: giovanni landoni, MD landoni.giovanni@hsr.it
Contact: elena bignami, MD bignami.elena@hsr.it
Italy
 
NCT00959569
GO/URC/ER/mm 459/DG
Not Provided
Landoni Giovanni, Vita-Salute University of Milano, Italy
Università Vita-Salute San Raffaele
Not Provided
Not Provided
Università Vita-Salute San Raffaele
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP