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Esmolol in Cardiac Surgery (BREVI)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2015 by Università Vita-Salute San Raffaele.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00959569
First Posted: August 14, 2009
Last Update Posted: October 21, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Università Vita-Salute San Raffaele
August 13, 2009
August 14, 2009
October 21, 2015
August 2009
December 2016   (Final data collection date for primary outcome measure)
Composite endpoint or number of dead patients and/or number of patients requiring prolonged ICU stay.
Reduce prolonged ICU stay / mortality
Complete list of historical versions of study NCT00959569 on ClinicalTrials.gov Archive Site
  • Number of patients with ventricular fibrillation after cardiopulmonary bypass
  • 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
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
 
Unknown status
200
December 2016
December 2016   (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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT00959569
GO/URC/ER/mm 459/DG
Not Provided
Not Provided
Not Provided
Landoni Giovanni, Vita-Salute University of Milano, Italy
Università Vita-Salute San Raffaele
Not Provided
Not Provided
Università Vita-Salute San Raffaele
October 2015

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