In vivo effects of C1-esterase inhibitor on innate immune response during endotoxemia in human - VECTOR II study
Completed
- Conditions
- activated immuun systemSystemic inflammation10027665
- Registration Number
- NL-OMON39199
- Lead Sponsor
- niversitair Medisch Centrum Sint Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
Age >= 18 and <= 35 years
Male
Healthy
Exclusion Criteria
Use of any medication
Congenital or acquired C1 inhibitory deficiency
Immune deficiency
Chronic inflammatory diseases
Smoking
History of allergic reaction to blood products
History, signs or symptoms of cardiovascular diseases
(Family) history of cerebrovasculair diseases under the age of 65 years
Previous vagal collaps
Hypertension (defined as RR systolic > 160 or RR diastolic > 90)
Hypotension (defined as RR systolic < 100 or RR diastolic < 50)
Renal impairment (defined as plasma creatinin > 120 µmol/l)
Liver enzyme abnormalities
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Main study endpoint is the phenotype of circulating neutrophils after LPS in<br /><br>the absence and presence of C1 INH substitution.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Concentration of circulating cytokines after LPS in the absence and presence<br /><br>of C1 INH substitution.<br /><br>- Study the possible differences between the circulatory and post-mitotic pool<br /><br>transit times of neutrophils in human blood in volunteers with and<br /><br>without C1-INH.<br /><br>- Pharmacokinetic and pharmacodynamic data will be collected with respect to<br /><br>the anti-inflammatory effects of C1 INH.<br /><br>- Effects on the PMN phenotype and function will be determined.<br /><br>- C1 INH concentration and activity as well as anaphylatoxin concentrations<br /><br>will be measured and compared to baseline values.</p><br>