Norepinephrine vs Norepinephrine and Dobutamine in Cardiogenic Shock
- Registration Number
- NCT03340779
- Lead Sponsor
- Central Hospital, Nancy, France
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Norepinephrine alone Norepinephrine Administration of norepinephrine with increasing dose Norepinephrine plus Dobutamine Norepinephrine Administration of norepinephrine and dobutamine
- Primary Outcome Measures
Name Time Method Obtention of a optimal cardiac output Hour 0 (H0), Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5 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.
- Secondary Outcome Measures
Name Time Method Change in hemodynamic parameters Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5 Arterial blood pressure (mmHg)
Occurence of arrythmia Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5 Notification of ventricular arrythmia
All-cause mortality Day 28 Mortality
Change in metabolic parameters Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5 Mottle (mottle score)
Trial Locations
- Locations (1)
CHU Nancy-Brabois
🇫🇷Vandoeuvre les nancy, France