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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

Brief Summary:
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 or disease Intervention/treatment Phase
Cardiac Surgery Drug: Esmolol Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Esmolol in Cardiac Surgery. A Randomized Controlled Trial With Clinical
Study Start Date : August 2009
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

Arm Intervention/treatment
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)



Primary Outcome Measures :
  1. Composite endpoint of number of dead patients and/or number of patients requiring prolonged ICU stay. [ Time Frame: Hospital stay (approximately 2 weeks) ]

Secondary Outcome Measures :
  1. Number of patients with ventricular fibrillation after cardiopulmonary bypass [ Time Frame: 30 days and 1 year ]
  2. Number of patients with low cardiac output syndrome [ Time Frame: 30 days and 1 year ]
  3. Number of patients requiring post-operative inotropic support [ Time Frame: 30 days and 1 year ]
  4. peak postoperative cardiac troponin level [ Time Frame: 30 days and 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: Giovanni Landoni, MD, Università Vita-Salute San Raffaele
ClinicalTrials.gov Identifier: NCT00959569     History of Changes
Other Study ID Numbers: GO/URC/ER/mm 459/DG
First Posted: August 14, 2009    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: April 2018

Keywords provided by Giovanni Landoni, 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
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists