Immunmodulatory effects of local anesthetics on neutrophils during sepsis

Conditions: Sepsis and severe sepsis
MedDRA version: 12.1Level: LLTClassification code 10040047Term: Sepsis

Registration Number: EUCTR2010-019345-26-DE

Lead Sponsor: Department of Anesthesiology and Intensive Care, University Hospital Muenster

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 30

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

Exclusion Criteria

- known allergy against local anesthetics
- known pregnancy
- patients with multi-organ failure
- terminal multiorgan failure or therapeutic limitations
- chronic renal failure with anuria or renal replacement therapy
- liver failure with MELD-Score >= 30
- myocardial infarction within the last three months
- congestive heart failure (EF<35%)
- cardiac arrythmia including sick-sinus syndrom, atriventricular block grade II and III
- cardiac shock

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.;Secondary Objective: - gastrointestinal function<br>- renal function<br>- pulmonary function<br>- liver function<br>- cardiovasculary function<br>- length of ICU stay<br>- mortality on day 28<br>- inflammatory parameters including CRP and Procalciton<br>- function of neutrophils (superoxide production, leukocyte adhesion, leucoyte transmigration);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 Outcome Measures