?Esmolol in cardiac surgery. A randomized controlled trial with clinical relevant endpoints.? - ND

• Conditions: patients undergoing cardiac surgery; MedDRA version: 9.1Level: LLTClassification code 10020823Term: Hypertensive heart disease

• Registration Number: EUCTR2009-012624-93-IT
• Lead Sponsor: OSPEDALE S. RAFFAELE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-08
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-end diastolic diameter >60 mm and an ejection fraction <50% -written informed consent -age >18 years
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-previous unusual response to esmolol -inclusion in other randomized studies -esmolol administration in the previous 30 days -emergency operation
-esmololo hypersensibility reaction

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to evaluate if the use of esmololo vs placebo may give a better outcome in paztients undergoing cardiosurgery.;Secondary Objective: to evaluate the incidence of ventricular fibrillation after extrabody circulation;Primary end point(s): to obtain a lower time of mortality and long time of hospedalization in intensive care unit