drugset / Trial / NCT03340779

Norepinephrine vs Norepinephrine and Dobutamine in Cardiogenic Shock

NCT03340779

Phase 3 Unknown 40 enrolled Central Hospital, Nancy, France
RandomizedCrossoverOpen-labelTreatment

Summary

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

Timeline

Start
2018-01-15
Primary completion
2019-11-01
Completion
2020-05-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Dobutamine Small molecule
Subject Norepinephrine Other / unclassified

Indications