Informations générales (source: ClinicalTrials.gov)
Norepinephrine vs Norepinephrine and Dobutamine in Cardiogenic Shock : a Randomised, Opened, Cross-over Study. Heart SHOCK-NORDOB Study (SHOCK-NORDOB)
Interventional
Phase 3
Central Hospital, Nancy, France (Voir sur ClinicalTrials)
janvier 2018
mai 2020
29 juin 2024
Cardiogenic shock is a frequent cause of admission and death in the intensive care unit.
Mortality is about 50%. Once the etiologic treatment has been done, for instance coronary
revascularization, management of the shock state is the cornerstone of the treatment.
Norepinephrine is the first-line vasopressor therapy because of its minor effect on heart
rhythm. Morever norepinephrine is a inotrope. In a previous study, we demonstrated that
increasing the norepinephrine dose increases cardiac index, cardiac power index, SVO2 and
tissue perfusion without acceleration of heart rate. Nevertheless, dobutamine remains the
first-line inotropic treatment. Dobutamine has a positive chronotropic effect that might
cause higher myocardial oxygen consumption. As a result, combination of vasopressor /
inotrope is still controversial.
The aim of this study was to compare hemodynamics and metabolics effects of 2 treatments
strategies (norepinephrine dose increasing or addition of dobutamine) in patients with
cardiogenic shock and optimised blood pressure level (MAP≥65 mmHg) under norepinephrine
treatment.
The secondary objectives were :
- To evaluate the efficacy of the treatments on micro- and macrocirculation parameters
- To evaluate the tolerance of the treatments
- To evaluate the dose and the admistration's kinetics of the treatments
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHU Nancy-Brabois - 54500 - Vandoeuvre les nancy - France | Thomas Auchet, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Patients with cardiogenic shock (ischemic, rythmic, valvular) defined : by cardiac
index (CI) < 2,2 L/min/m² or CI < 2,5 L/min/m² under vasopressor/inotropic treatment
and organ hypoperfusion signs : mottles, capillary refill time , urine output < 0,5
mL/kg/hour during at least one hour ou renal replacement therapy, consciouness
impairment, pulmonary oedema, hyperlactatemia (> 2 mmoL/L)
- Mean arterial pressure > 65 mmHg under norepinephrine treatment
- Patients with social coverage
- Patients with cardiogenic shock (ischemic, rythmic, valvular) defined : by cardiac
index (CI) < 2,2 L/min/m² or CI < 2,5 L/min/m² under vasopressor/inotropic treatment
and organ hypoperfusion signs : mottles, capillary refill time , urine output < 0,5
mL/kg/hour during at least one hour ou renal replacement therapy, consciouness
impairment, pulmonary oedema, hyperlactatemia (> 2 mmoL/L)
- Mean arterial pressure > 65 mmHg under norepinephrine treatment
- Patients with social coverage
- < 18 years old
- Pregnancy
- Inclusion in other drug study
- Poisonings with cardiotoxicants
- Patient with intra-aortic ballon pump, extracorporeal life support
- Patient under guardianship