Esmolol in Cardiac Surgery

NCT ID: NCT00959569

Last Updated: 2018-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2018-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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esmolol

the study group will receive esmolol (1-3 mg/kg)

Group Type EXPERIMENTAL

Esmolol

Intervention Type DRUG

esmolol (1-3 mg/kg) during cardiac surgery

normosaline

normosaline (same ml of the study drug)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

normosaline (same ml of the study drug)

Interventions

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Esmolol

esmolol (1-3 mg/kg) during cardiac surgery

Intervention Type DRUG

Placebo

normosaline (same ml of the study drug)

Intervention Type DRUG

Other Intervention Names

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Beta-blocker; Beta blocker; breviblock

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Università Vita-Salute San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Giovanni Landoni

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Vita-Salute University

Milan, , Italy

Site Status

Countries

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Italy

References

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Zangrillo A, Turi S, Crescenzi G, Oriani A, Distaso F, Monaco F, Bignami E, Landoni G. Esmolol reduces perioperative ischemia in cardiac surgery: a meta-analysis of randomized controlled studies. J Cardiothorac Vasc Anesth. 2009 Oct;23(5):625-32. doi: 10.1053/j.jvca.2009.01.003. Epub 2009 Mar 18.

Reference Type BACKGROUND
PMID: 19297196 (View on PubMed)

Crescenzi G, Rosica C, Marino G, Serini SM, Covello RD, Landoni G, Zangrillo A. The use of esmolol to treat systolic anterior motion of the mitral valve after mitral valve repair. Eur J Anaesthesiol. 2008 Apr;25(4):342-3. doi: 10.1017/S0265021507002876. No abstract available.

Reference Type BACKGROUND
PMID: 18334040 (View on PubMed)

Landoni G, Zambon M, Zangrillo A. Reducing perioperative myocardial infarction with anesthetic drugs and techniques. Curr Drug Targets. 2009 Sep;10(9):858-62. doi: 10.2174/138945009789108837. Epub 2009 Sep 1.

Reference Type BACKGROUND
PMID: 19538174 (View on PubMed)

Crescenzi G, Landoni G, Zangrillo A, Guarracino F, Rosica C, La Canna G, Alfieri O. Management and decision-making strategy for systolic anterior motion after mitral valve repair. J Thorac Cardiovasc Surg. 2009 Feb;137(2):320-5. doi: 10.1016/j.jtcvs.2008.08.018.

Reference Type BACKGROUND
PMID: 19185145 (View on PubMed)

Other Identifiers

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GO/URC/ER/mm 459/DG

Identifier Type: -

Identifier Source: org_study_id

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