MedPath

Comparison of norepinephrine and dobutamine in patients in cardiogenic shock

Phase 1
Conditions
Patients over 18 years of age with cardiogenic shock
MedDRA version: 20.0Level: LLTClassification code 10040563Term: Shock cardiogenicSystem Organ Class: 10007541 - Cardiac disorders
MedDRA version: 20.0Level: PTClassification code 10007625Term: Cardiogenic shockSystem Organ Class: 10007541 - Cardiac disorders
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Registration Number
EUCTR2020-004881-20-IT
Lead Sponsor
AZIENDA USL TOSCANA SUD EST Sezione di Arezzo
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
All
Target Recruitment
46
Inclusion Criteria

Cardiogenic shock with: systolic systemic blood pressure (PAS) <90 mmHg or mean arterial pressure (MAP) <60 mmHg for at least 30 consecutive minutes and the need for pharmacological support (inotropic and / or vasopressors) to maintain a PAS> 90 mmHg or MAP > 60 mmHg;
Over the age of 18;
Enrollment within 3 hours of the acute event,
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 46
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 46

Exclusion Criteria

Pregnancy in progress;
Presence of at least moderate aortic and / or mitral valve disease;
Septic or hypovolemic shock
Mechanical complications of acute myocardial infarction (rupture of the free wall of the heart, interventricular defect, papillary rupture.
Arrhythmic storm, persistent or chronic tachycardic atrial fibrillation.
Patient enrolled in another study
Infusion of inotropes / vasoconstrictors already in place at the time of randomization

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath