Esmolol in Cardiac Surgery (BREVI)

October 9, 2018 updated by: Giovanni Landoni, Università Vita-Salute San Raffaele

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milano, Italy
        • Vita-Salute University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • Beta-blocker; Beta blocker; breviblock
Placebo Comparator: normosaline
normosaline (same ml of the study drug)
Drug: Placebo
normosaline (same ml of the study drug)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patients with ventricular fibrillation after cardiopulmonary bypass
Time Frame: 30 days and 1 year
30 days and 1 year
Number of patients with low cardiac output syndrome
Time Frame: 30 days and 1 year
30 days and 1 year
Number of patients requiring post-operative inotropic support
Time Frame: 30 days and 1 year
30 days and 1 year
peak postoperative cardiac troponin level
Time Frame: 30 days and 1 year
30 days and 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università Vita-Salute San Raffaele

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

August 13, 2009

First Submitted That Met QC Criteria

August 13, 2009

First Posted (Estimate)

August 14, 2009

Study Record Updates

Last Update Posted (Actual)

October 10, 2018

Last Update Submitted That Met QC Criteria

October 9, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GO/URC/ER/mm 459/DG

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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