Norepinephrine vs Norepinephrine and Dobutamine in Cardiogenic Shock

Central Hospital, Nancy, France40 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cardiogenic Shock

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 Exclusion Criteria: * \< 18 years old * Pregnancy * Inclusion in other drug study * Poisonings with cardiotoxicants * Patient with intra-aortic ballon pump, extracorporeal life support * Patient under guardianship

Outcomes

Primary Outcomes

Obtention of a optimal cardiac output

Measure of increase of cardiac index \> 15% (L/min/m²), increase of organ perfusion assessed by : lactate clearance \> 15% (mmoL/L), decrease of mottling (decrease of 2 points of Mottling score), increase of musculaire oxygen saturation measured by NIRS \> 15% (rSo2%), increase of urine output \> 50% (mL/h), increase of SVcO2 \> 15%(%) Evaluation of occurence of side effects : Increase of heart rate \> 15% (bpm) , 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.

Time frame: Hour 0 (H0), Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5