In vivo effects of C1-esterase inhibitor on innate immune response during endotoxemia in human.
- Conditions
- inflammationsepsis1002766510002252
- Registration Number
- NL-OMON32783
- Lead Sponsor
- niversitair Medisch Centrum Sint Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
Healthy young male adults (18-35 years)
Exclusion Criteria
Use of any medication
Congenital or acquired C1 inhibitor deficiency
Immune deficiency
History of allergic reaction to blood products
Chronic inflammatory diseases
Smoking
History, signs or symptoms of cardiovascular disease
(Family) history of cerebrovascular disease
Previous vagal collaps
Hypertension (defined as RR systolic > 160 or RR diastolic > 90)
Hypotension (defined as RR systolic < 100 or RR diastolic < 50)
Renal impairement (defined as plasma creatinin >120 µmol/l)
Liver enzyme abnormalities or positive hepatitis serology
Positive HIV test
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Main study endpoint is the concentration of circulating cytokines and C<br /><br>reactive protein after LPS in the absence and presence of C1 INH substitution.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Pharmacokinetic and pharmacodynamic data will be collected with respect to the<br /><br>anti-inflammatory effects of C1 INH. Effects on the PMN phenotype and function<br /><br>will be determined. C1 INH concentration and activity as well as anaphylatoxin<br /><br>concentrations will be measured and compared to baseline values. </p><br>