The purpose of this study is to investigate the effects on systemic hemodynamics, microcirculation and organ function of human Protein C concentrate in patients with sepsis and septic shock.
Sixty septic patients with plasma protein C activity \< 60 % will be enrolled in the study. Patients will be randomly allocated to be treated with either a) a continuous infusion of human Protein C concentrate at 3 UI/Kg/hr for 72 hours to reach plasma protein C activity between 70 and 120 % b)to a continuous infusion of activated protein C at 24 micrograms/Kg/hr for 96 hours, c) a standard teatment(control; each n = 20). In all groups, norepinephrine will be titrated to achieve a mean arterial pressure (MAP) between 65 and 75 mmHg. Data from right heart catheterization, from microcirculation (SDF imaging) and from organ function as well as norepinephrine requirements will be obtained at baseline and after 24, 48, 72 hours.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Continuous infusion of human protein C concentrate at the dose of 3 UI/Kg/Hr to reach a protein C plasma activity of 70-120%
Continuous infusion of activated protein C at the dose of 24 micrograms/Kg/Hr for 96 hours
Standard treatment
Departement of Anesthesiology and Intensive Care of the University of Rome La Sapienza
Rome, Italy
plasma protein C activity
Time frame: over a period of 72 hours
sublingual microcirculatory blood flow
Systemic hemodynamics,sublingual microcirculatory blood flow, organ function, citokynes.
Time frame: over a period of 72 hours
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