Clinical Trial: Study Comparing the Efficacy and Tolerability of Epinephrine and Norepinephrine in Cardiogenic Shock

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Optimizing the Use of Vasopressor After Coronary Reperfusion in Cardiogenic Shock Secondary to Myocardial Infarction. Pathophysiological Study Comparing the Efficacy and C

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 Summary:

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.


Sponsor: Central Hospital, Nancy, France

Current Primary Outcome: Compared effects of investigated drugs on cardiac index [ Time Frame: H0; H2, H4, H6, H12, H24, H48 and H72 ]

effectiveness of the treatment assessed by the evolution of cardiac index


Original Primary Outcome: Compared effects of investigated drugs on cardiac index [ Time Frame: participants will be followed until release from ICU, an expected average of 2 weeks ]

effectiveness of the treatment assessed by the evolution of cardiac index


Current Secondary Outcome:

  • pro/anti-inflammatory cytokines [ Time Frame: H0, H24, H48 and H72 ]
    Compared effects of investigated drugs on pro/anti-inflammatory cytokines
  • BNP [ Time Frame: H0, H24, H48 and H72 ]
    Compared effects of investigated drugs on BNP
  • Troponin [ Time Frame: H0, H24, H48 and H72 ]
    Compared effects of investigated drugs on Troponin
  • catecholamine doses [ Time Frame: H0, H24, H48 and H72 ]
    Compared effects of investigated drugs on the catecholamine doses
  • organ failure (SOFA Score) [ Time Frame: H0, H24, H48 and H72 ]
    Compared effects of investigated drugs on the organ failure
  • Lactate clearance [ Time Frame: H0, H2, H6, H12, H24 and H48 ]
    Compared effects of investigated drugs on the Lactate clearance
  • heart rate [ Time Frame: H0, H2, H4, H6, H12, H24, H48 and H72 ]
    Compared effects of investigated drugs on heart rate and the incidence of arrhythmia
  • cardiac power index [ Time Frame: H0, H2, H4, H6, H12, H24, H48 and H72. ]
    Compared effects of investigated drugs on cardiac power
  • SVO2 [ Time Frame: H0, H2, H4, H6, H12, H24, H48 and H72. ]
    Compared effects of investigated drugs on the SVO2
  • cardiac double product [ Time Frame: H0, H2, H4, H6, H12, H24, H48 and H72. ]
    Compared effects of investigated drugs on the cardiac double product
  • refractory cardiogenic shock [ Time Frame: H0, H2, H4, H6, H12, H24, H48 and H72. ]
    compared effects of the investigated drugs on the occurrence of refractory cardiogenic shock


Original Secondary Outcome:

  • Compared effects of investigated drugs on heart rate and cardiac power index [ Time Frame: participants will be followed until release from ICU, an expected average of 2 weeks ]
  • pro/anti-inflammatory cytokines [ Time Frame: participants will be followed until release from ICU, an expected average of 2 weeks ]
    establish the pro/anti-inflammatory profile of cardiogenic shock in terms of cytokines and its evolution


Information By: Central Hospital, Nancy, France

Dates:
Date Received: May 10, 2011
Date Started: September 2011
Date Completion:
Last Updated: April 21, 2017
Last Verified: April 2017