A Phase 3 interventional study of Norepinephrine in Cardiogenic Shock, sponsored by Central Hospital, Nancy, France. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-14.
Sponsored by Central Hospital, Nancy, France · Phase 3, Interventional, and Treatment
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 :
Inclusion Criteria:
Exclusion Criteria:
Administration of norepinephrine with increasing dose
Drug: Norepinephrine
Administration of norepinephrine and dobutamine
Drug: Norepinephrine
After obtention of a mean arterial pressure (MAP) of 65 mmHg with infusion of norepinephrine, patients with cardiogenic shock receive for 3 hours either increasing doses of norepinephrine (with a maximal MAP of 85 mmHg) or dobutamine. There is a wash-out phase of 30 minutes (decrease of norepinephrine dose or weaning of dobutamine). The third phase of the study is the administration of the comparator treatment during 3 hours. After the 6.5 hours of the study, the hemodynamic management is up to the physician.
Also known as: Dobutamine
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
Change in hemodynamic parameters
Measure of heart rate (bpm),
Time frame: Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5
Occurence of arrythmia
Notification of atrial arrythmia
Time frame: Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5
Change in hemodynamic parameters
Cumulated dose of catecholamines
Time frame: Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5
All-cause mortality
Mortality
Time frame: Day 28
Change in hemodynamic parameters
Arterial blood pressure (mmHg)
Time frame: Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5
Change in metabolic parameters
SVcO2 (%)
Time frame: Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5
Change in metabolic parameters
Lactate clearance (mmol/L)
Time frame: Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5
Change in metabolic parameters
Muscular oxygen saturation (%)
Time frame: Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5
Change in metabolic parameters
Urine output (mL/h)
Time frame: Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5
Change in metabolic parameters
Mottle (mottle score)
Time frame: Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5
Occurence of arrythmia
Notification of ventricular arrythmia
Time frame: Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5
Plan to share: No
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Central Hospital, Nancy, France