Trial record 9 of 322 for:    Open Studies | "Cardiac Surgical Procedures"

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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 15, 2014