Study Comparing the Efficacy and Tolerability of Epinephrine and Norepinephrine in Cardiogenic Shock
- Conditions
- Cardiogenic Shock
- Interventions
- Registration Number
- NCT01367743
- Lead Sponsor
- Central Hospital, Nancy, France
- Brief Summary
The efficacy and tolerability of norepinephrine and epinephrine in cardiogenic shock after reperfused myocardial infarction will be compared, by following cardiac index evolution as main criteria. The study is a pilot pathophysiological study, randomized, double blind and multicenter.
- Detailed Description
Cardiogenic shock secondary to myocardial infarction is a frequent pathology in reanimation and is associated with high mortality (50%). Hemodynamic management and notably the choice of vasopressor in cardiogenic shock states secondary to myocardial infarction (cardiac index \< 2.2 l/min/m-2) is not codified. There are two opposite views: a) the first is based on the fact that an hypotensive patient with low cardiac output is primarily in need of an inotropic agent and that, consequently, epinephrine is the molecule of choice (inotropic and vasoconstrictor); b) the second is based on the fact that hypotension also reflects a certain degree of vascular failure and vascular vasoplegia and therefore norepinephrine is the molecule of choice along with, if needed, the eventual addition of dobutamine in order to separately titrate vasoconstriction and inotropism.
Study hypotheses: epinephrine could facilitate myocardial function by providing the latter with its preferred substrate (lactate) and thus induce a higher cardiac index along with increased energy expenditure. Norepinephrine is the therapy of choice of hypotensive states; nevertheless its lack of inotropic effect could theoretically exacerbate myocardial failure. Thus, the aim of the study is to compared the efficiency and the tolerability of norepinephrine and epinephrine in cardiogenic shock after reperfused myocardial infarction.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
- man or woman older than 18 years
- cardiogenic shock due to myocardial infarction treated by angioplasty
- SAP < 90 MM Hg or MAP < 65 mm Hg without vasopressor or vasopressor necessity
- sign of tissue hypoperfusion
- cardiac index < 2.2 l/mn/m2 in the absence of vasopressive or inotropic therapy
- pulmonary artery occlusion pressure > 15 mmHg or echocardiographic evidence of high pressure (mitral profile)
- exclusion of covert hypovolemia : Delta PP if feasible should be > 13% (patient adapted to the ventilator and sinus rhythm) and /or no response to passive leg raising
- ejection fraction < 40% in ultrasound without inotrope support. This criteria will not be taken into account in instances of treatment with dopamine, norepinephrine, epinephrine, dobutamine or milrinone.
- shock of other origin
- immediate indications for mechanical assistance device
- minor aged patients
- patients for whom written consent - by patient or family - has not been obtained. Given the seriousness of the medical situation at the time of inclusion, patient consent will be difficult if not impossible to obtain. The inclusion will only be possible after information is provided and consent is obtained from a family member. As soon as possible, protocol information will be issued to the patient in order to obtain consent for continuance.
- cardiac arrest with early signs of cerebral anoxia.
- septic, toxic and obstructive cardiomyopathy
- arrhythmogenic cardiomyopathy
- patient with coronary insufficiency
- patient with ventricular rhythm disorders
- patient treated with a medicine listed in contre indication
- patient without social assurance
- patient major under legal protection or safeguard justice
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description norepinephrine norepinephrine perfusion - epinephrine epinephrine perfusion -
- Primary Outcome Measures
Name Time Method Compared effects of investigated drugs on cardiac index H0; H2, H4, H6, H12, H24, H48 and H72 effectiveness of the treatment assessed by the evolution of cardiac index
- Secondary Outcome Measures
Name Time Method Troponin H0, H24, H48 and H72 Compared effects of investigated drugs on Troponin
cardiac power index H0, H2, H4, H6, H12, H24, H48 and H72. Compared effects of investigated drugs on cardiac power
pro/anti-inflammatory cytokines H0, H24, H48 and H72 Compared effects of investigated drugs on pro/anti-inflammatory cytokines
organ failure (SOFA Score) H0, H24, H48 and H72 Compared effects of investigated drugs on the organ failure
Lactate clearance H0, H2, H6, H12, H24 and H48 Compared effects of investigated drugs on the Lactate clearance
heart rate H0, H2, H4, H6, H12, H24, H48 and H72 Compared effects of investigated drugs on heart rate and the incidence of arrhythmia
cardiac double product H0, H2, H4, H6, H12, H24, H48 and H72. Compared effects of investigated drugs on the cardiac double product
refractory cardiogenic shock H0, H2, H4, H6, H12, H24, H48 and H72. compared effects of the investigated drugs on the occurrence of refractory cardiogenic shock
BNP H0, H24, H48 and H72 Compared effects of investigated drugs on BNP
catecholamine doses H0, H24, H48 and H72 Compared effects of investigated drugs on the catecholamine doses
SVO2 H0, H2, H4, H6, H12, H24, H48 and H72. Compared effects of investigated drugs on the SVO2
Trial Locations
- Locations (11)
CHU de BESANCON / Hôpital Jean Minjoz
🇫🇷Besancon, France
CHU de DIJON
🇫🇷Dijon, France
Nancy Brabois university hospital
🇫🇷Vandoeuvre les Nancy, Meurthe Et Moselle, France
CHU de LIMOGES Hôpital Dupuytren
🇫🇷Limoges, France
APHM Hôpital NORD
🇫🇷Marseille, France
Chr Metz Thionville
🇫🇷Metz, France
CH de MULHOUSE
🇫🇷Mulhouse, France
AP-HP-Hôpital Cochin
🇫🇷Paris, France
CHU de STRASBOURG / NHC
🇫🇷Strasbourg, France
Chru Tours
🇫🇷Tours, France
CHU Toulouse
🇫🇷Toulouse, France