Esmolol during mitral valve surgery
Phase 1
Active, not recruiting
- Conditions
- Patients undergoing mitral valve surgery.MedDRA version: 20.0Level: LLTClassification code 10027716Term: Mitral insufficiencySystem Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2018-000680-93-IT
- Lead Sponsor
- IRCCS ISTITUTO CLINICO HUMANITAS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 550
Inclusion Criteria
xxxxxxxxx
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 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 250
Exclusion Criteria
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Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The aim of this study is to compare the efficacy of a high-dose continuous infusion of esmolol versus placebo on the primary outcomes of improving myocardial protection, weighed through CK-MB and cTnI release, and the incidence of postoperative low cardiac output syndrome.;Secondary Objective: To evaluate the impact of esmolol versus placebo on key secondary endpoints including: operative mortality, ICU and hospital stay, and the most important clinical outcomes: stroke, postoperative myocardial infarction, renal failure, and prolonged need for mechanical ventilation.;Primary end point(s): xxxxxxxx;Timepoint(s) of evaluation of this end point: Evaluation durin postoperative course
- Secondary Outcome Measures
Name Time Method Secondary end point(s): xxxxxxxx;Timepoint(s) of evaluation of this end point: Evaluation durin postoperative course