Esmolol during mitral valve surgery

Postoperative effects of high-dose esmolol during mitral valve surgery for mitral regurgitation. - n.a.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-000680-93-IT

Enrollment

550

Registered

2021-01-07

Start date

2018-06-05

Completion date

Unknown

Last updated

2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients undergoing mitral valve surgery. MedDRA version: 20.0 Level: LLT Classification code 10027716 Term: Mitral insufficiency System Organ Class: 100000004849

Interventions

Trade Name: BREVIBLOC - 10 MG/ML SOLUZIONE PER INFUSIONE SACCA DA 250 ML Product Name: BREVIBLOC Product Code: n.a. Pharmaceutical Form: Solution for infusion INN or Proposed INN: ESMOLOLO CAS Number:

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: xxxxxxxx

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
Secondary end point(s): xxxxxxxx;Timepoint(s) of evaluation of this end point: Evaluation durin postoperative course	—

Countries

Italy

Contacts

Public Contactn.a.

IRCCS Istituto Clinico Humanitas

luciano.ravera@humanitas.it0282241

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026