Sepsis Clinical Trial
Official title:
In Vivo Effects of C1-esterase Inhibitor on the Innate Immune Response During Human Endotoxemia - A Randomized Controlled Pilot Study
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.
n/a
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science
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