Immunmodulatory effects of local anesthetics on neutrophils during sepsis

INTERVENTION: Trade Name: Lidocard B. Braun 2 % Pharmaceutical Form: Solution for injection CAS Number: 6108‐05‐0 Other descriptive name: LIDOCAINE HYDROCHLORIDE MONOHYDRATE Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20‐ Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use CONDITION: Sepsis and severe sepsis ; MedDRA version: 12.1 Level: LLT Classification code 10040047 Term: Sepsis PRIMARY OUTCOME: Main Objective: To evaluate the effects of systemic low‐dose lidocaine on rolling velocity of human neutrophils in whole blood on ICAM‐1 upon E‐selectin engagement 6 hours after start of intervention in septic patients. Primary end point(s): The primary variable is defined as the rolling velocity of neutrophils on E‐Selectin and ICAM‐1 after 6 hours of start of intervention Secondary Objective: ‐ gastrointestinal function; ‐ renal function; ‐ pulmonary function; ‐ liver function; ‐ cardiovasculary function; ‐ length of ICU stay; ‐ mortality on day 28; ‐ inflammatory parameters including CRP and Procalciton; ‐ function of neutrophils (superoxide production, leukocyte adhesion, leucoyte transmigration) INCLUSION CRITERIA: ‐ presence of sepsis due to an assumed or assured infection with a systemic inflammatory response syndrome (SIRS) ‐ Male or female patients older than 18 years ‐ written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range