An open-label randomized controlled experimental endotoxemia study on the effects of the cytokine-adsorbing hemofilter CytoSorb on the development of immunoparalysis in humans
Phase 4
Recruiting
- Conditions
- Blood stream infectionimmunoparalysis1002766510004018
- Registration Number
- NL-OMON55310
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 24
Inclusion Criteria
- Written informed consent
- Male
- Age * 18 and * 35 years
- Healthy (as determined by medical history, physical examination, vital signs,
12-lead electrocardiogram (ECG) and routine clinical laboratory parameters)
Exclusion Criteria
- Use of any medication
- Smoking
- Hypersensitivity to any of the (non)investigational products or their
excipients
- History of:
- Any immune-related disorder
- Aneurysmal or hemorrhagic disease
- Renal or hepatic impairment
- Recent infection (<2 weeks)
- Previous LPS administration
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Plasma IL-6 levels during the second LPS challenge. Comparison of CytoSorb<br /><br>group with control group. IL-6 is an archetypal pro-inflammatory cytokine with<br /><br>high relevance to sepsis.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Plasma levels of other inflammatory cytokines (including, but not limited to<br /><br>IL-6, IL-8, IL-10, MCP-1, CXCL-10, MIP-1*, MIP-1*, and G-CSF) during the second<br /><br>LPS chal-lenge.<br /><br>- mHLA-DR expression.<br /><br>- Plasma levels of inflammatory cytokines (including, but not limited to IL-6,<br /><br>IL-8, IL-10, MCP-1, CXCL-10, MIP-1*, MIP-1*, and G-CSF) during the first LPS<br /><br>challenge<br /><br>- Norepinephrine sensitivity during the first LPS challenge.<br /><br>- Cytokine concentrations in afferent and efferent tubing of the CytoSorb<br /><br>filter. Togeth-er with the blood flow, cytokine clearance by the filter can be<br /><br>calculated.<br /><br>- Endotoxemia-induced changes in leukocyte numbers and differential count<br /><br>- Endotoxemia-induced increase in body temperature<br /><br>- Endotoxemia-induced symptoms<br /><br>- Endotoxemia-induced hemodynamic alterations<br /><br>- Endotoxemia-induced increase in markers of endothelial injury (VCAM/ICAM)</p><br>