Cardiogenic Shock
Conditions
Interventions
Trade Name: NORADRENALINE MYLAN
Product Name: NORADRENALINE MYLAN
Pharmaceutical Form: Solution for infusion
Trade Name: Dobutamine
Pha
Sponsors
CHRU NANCY
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with cardiogenic shock (ischemic, rythmic, valvular) defined by : - Cardiac index (CI) 2 mmoL/L) - Mean arterial pressure > 65 mmHg under norepinephrine treatement - Patients with social coverage - Patient having given his / her consent, free, informed and in writing. If not, consent will be obtained from a family member / support person, if present. As soon as possible, the patient will be informed and his / her consent will be requested for the possible continuation of the research 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 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: < 18 years old Pregnancy Inclusion in other drug study in cardiogenic shock , inclusion in study with medical device (for instance valve replacement) Poisonings with cardiotoxicants Patient with intra-aortic ballon pump, extracorporeal life support, ventricular support device Patient under guardianship
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Norepinephrine alone vs Norepinephrine and Dobutamine in cardiogenic shock : a randomised, opened, cross-over study. Heart SHOCK-NORDOB Study; Secondary Objective: - To evaluate the efficacy of the treatments on micro- and macrocirculation parameters - To evaluate the dose and the admistration's kinetics of the treatments - To evaluate the dose and the admistration's kinetics of the treatments ; Primary end point(s): Composite criteria for efficacy of treatment : - increase of cardiac index > 15%, - increase of organ perfusion assessed by : -lactate clearance > 15%, - decrease of mottling (decrease of 2 points of Mottling score), - increase of musculaire oxygen saturation measured by NIRS > 15%, - urine output 50%, - increase of SVcO2 > 15% ; and safety (occurence of side effects) : - increase of heart rate > 15% , - increase of oxygen consumption evaluated by decrease of ratio mean arterial pressure / heart rate > 15% (Buffington ratio). The primary endpoint is defined by the presence of 2 efficacy criterias without any side effects. ;Timepoint(s) of evaluation of this end point: During hospitalization in the resuscitation department. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Evaluation of efficacy by measure of heart rate, blood pressure, SVcO2, lactate clearance, muscular oxygen musculare, urine output, mottle - Evaluation of tolerance by measure of atrial and ventricular arythmia - Measure of catecholamines doses, time to reach the target ;Timepoint(s) of evaluation of this end point: During hospitalization in the resuscitation department. | — |
Countries
France
Contacts
Public ContactDirection Recherche et Innovation
CHRU de Nancy
Outcome results
None listed