Clinical Trial: In Vivo Effects of C1-esterase Inhibitor on the Innate Immune Response During Human Endotoxemia - VECTOR II
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: In Vivo Effects of C1-esterase Inhibitor on the Innate Immune Response During Human Endotoxemia - A Randomized Controlled Pilot Study
Brief Summary:
Excessive inflammation is associated with tissue damage caused by over-activation of the innate immune system. This can range from mild disease to extreme conditions, such as multiple organ dysfunction syndrome (MODS) and acute respiratory distress (ARDS). In marked contrast to adaptive immunity which is very sensitive to immune modulators such as steroids, the innate immune system cannot be sufficiently targeted by currently available anti-inflammatory drugs.
The investigators hypothesize that pre-treatment with C1-esterase inhibitor in a human endotoxemia model can modulate the innate immune response.
In this study, human endotoxemia will be used as a model for inflammation. Subjects will, prior to endotoxin administration, receive C1 esterase inhibitor or placebo. Blood will be sampled to determine the levels of markers of the innate immune response.
Detailed Summary:
Sponsor: Radboud University
Current Primary Outcome: Neutrophil phenotype and redistribution [ Time Frame: 8 hrs after LPS administration ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Cytokines and other markers of inflammation [ Time Frame: 8 hrs after LPS administration ]
- C1-inhibitor and complement concentration and activity [ Time Frame: 8 hrs after LPS administration ]
Original Secondary Outcome: Same as current
Information By: Radboud University
Dates:
Date Received: January 4, 2013
Date Started: September 2013
Date Completion:
Last Updated: November 27, 2014
Last Verified: November 2014
