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Esmolol in Cardiac Surgery (BREVI)

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ClinicalTrials.gov Identifier: NCT00959569
Recruitment Status : Recruiting
First Posted : August 14, 2009
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
Giovanni Landoni, Università Vita-Salute San Raffaele

August 13, 2009
August 14, 2009
April 6, 2018
August 2009
June 2018   (Final data collection date for primary outcome measure)
Composite endpoint of number of dead patients and/or number of patients requiring prolonged ICU stay. [ Time Frame: Hospital stay (approximately 2 weeks) ]
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 [ Time Frame: 30 days and 1 year ]
  • Number of patients with low cardiac output syndrome [ Time Frame: 30 days and 1 year ]
  • Number of patients requiring post-operative inotropic support [ Time Frame: 30 days and 1 year ]
  • peak postoperative cardiac troponin level [ Time Frame: 30 days and 1 year ]
--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.
 
Recruiting
200
Same as current
July 2018
June 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
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
Not Provided
Not Provided
Giovanni Landoni, Università Vita-Salute San Raffaele
Università Vita-Salute San Raffaele
Not Provided
Not Provided
Università Vita-Salute San Raffaele
April 2018

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