Shock, Septic Clinical Trial
Official title:
Effect of a Continuous Infusion of Esmolol on Stroke Volume in Patients With Hyperdynamic Vasoplegic Septic Shock: a Multicentre, Randomized, Double-blind Trial
The main objective of this study is to evaluate the effectiveness of the administration of a
short acting beta-blocker in terms of effective increase in stroke volume (at least 15%)
after 4 hours initiation of therapy in septic shock in patients with a hyperkinetic profile
after 12-24 hours of care.
This research seeks to demonstrate that the proportion of patients with an increase in the
systolic ejection superior or equal to 15% (relative to baseline) at four hours is different
between the two arms of the study: (1) an experimental arm where patients receive an esmolol
infusion according to a predetermined procedure and (2) a control arm where patients receive
a saline infusion according to a predetermined procedure.
The secondary objectives are to compare the following items between the two arms of the
study:
A. Central venous oxygen saturation at 4 hours (H4)
B. Changes in plasma concentration of lactates between H0 and H4
C. Changes in the tissue oxygen saturation between H0 and H4
D. Changes in echocardiographic parameters of systolic function of the left ventricle (LV)
and right ventricle (RV), as well as diastolic LV function between H0 and H4
E. Vascular Filling volume during the study period
F. Kidney function: urine output and creatinine changes between H0 and H4
G. The required vasopressor time between H0 and H4
H. Use of positive inotropic agents
I. The inflammatory response via the analysis of HLA-DR between H0 and H4 and M1 / M2
responses at H4
J. The duration of ICU stay, mortality, morbidity in terms of organ failures
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