Patients over 18 years of age with cardiogenic shock MedDRA version: 20.0 Level: LLT Classification code 10040563 Term: Shock cardiogenic System Organ Class: 10007541 - Cardiac disorders MedDRA version: 20.0 Level: LLT Classification code 10040563 Term: Shock cardiogenic System Organ Class: 10007541 - Cardiac disorders MedDRA version: 20.0 Level: PT Classification code 10007625 Term: Cardiogenic shock System Organ Class: 10007541 - Cardiac disorders MedDRA version: 20.0 Level: PT Classifica
Conditions
Interventions
Trade Name: DOBUTAMINA (BIOINDUSTRIA LI.M.)
Product Name: DOBUTAMINA (BIOINDUSTRIA LI.M.)
Product Code: [034449013]
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: DOBU
Sponsors
AZIENDA USL TOSCANA SUD EST Sezione di Arezzo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Cardiogenic shock with: systolic systemic blood pressure (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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of blood lactate concentration variation between the baseline and 72 hours after randomization, in the two treatment arms.;Secondary Objective: Evaluation of the incidence of death or the need to receive ECMO (Extracorporeal membrane oxygentaion) / LVAD (Left ventricular Assist Device) implantation at 72 hours after randomization and at discharge.;Primary end point(s): Variation of blood lactate concentration measured as the difference between maximum value at baseline: 0-1 hours after randomization and 72 hours after randomization, in the two treatment arms. In case of death: Variation of blood lactate concentration measured as the difference between maximum value at baseline: 0-1h from randomization and last available lactate value from randomization, in both of arms of treatment.;Timepoint(s) of evaluation of this end point: - at basal time: 0-1 hours after randomization - at 72 hours after randomization - In case of death: at basal time 0-1 hours after randomization and the last available blood lactate value | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1-death or need for ECMO / LVAD at 72 h from randomization 2-death or need to resort to ECMO / LVAD upon discharge 3- Variation of SOFA (Sequential Organ Failure Assessment) score measured as the difference between maximum value at baseline: 0-1 hours after randomization and 72 hours after randomization; and between maximum value at baseline: 0-1 hours after randomization and 7 days after randomization, in both of arms of treatment. 4-AUC of lactates (0-72 h) 5-need for further inotropic extra trial at 72h;Timepoint(s) of evaluation of this end point: - at basal time: 0-1 hours after randomization - at 72 hours after randomization - at 7 days after randomization | — |
Countries
Italy
Contacts
Public ContactU.O.C. Cardiologia
Ospedale della Misericordia, Grosseto
Outcome results
None listed