patients undergoing cardiac surgery MedDRA version: 9.1 Level: LLT Classification code 10020823 Term: Hypertensive heart disease
Conditions
Interventions
Trade Name: BREVIBLOC
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Esmolol
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Phar
Sponsors
OSPEDALE S. RAFFAELE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -end diastolic diameter >60 mm and an ejection fraction 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
Exclusion criteria: -previous unusual response to esmolol -inclusion in other randomized studies -esmolol administration in the previous 30 days -emergency operation -esmololo hypersensibility reaction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy
Outcome results
None listed