Immunmodulatory effects of local anesthetics on neutrophils during sepsis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-019345-26-DE

Enrollment

Registered

2010-03-25

Start date

2010-06-02

Completion date

Unknown

Last updated

2014-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis and severe sepsis MedDRA version: 12.1 Level: LLT Classification code 10040047 Term: Sepsis

Interventions

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)/m

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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 - 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);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	—

Measure

Time frame

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 - 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);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

—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026