Endotoxemia Clinical Trial
Official title:
The Effects of Acetylsalicylic Acid on Immunoparalysis Following Human Endotoxemia
Rationale:
The last years, research focus has moved to immunostimulatory agents in order to restore or
increase the functionality of the immune system during sepsis-induced immunoparalysis.
Epidemiologic data show that prehospital use of low dose acetylsalicylic acid (ASA) is
associated with improved outcome of sepsis. Experimental data indicate that ASA exerts
pro-inflammatory effects during systemic inflammation. However, it remains to be determined
whether treatment with ASA improves immune function once immunoparalysis has developed and
whether prehospital use of low dose ASA prevents the development of immunoparalysis. In the
former case, ASA is a potential immunostimulatory therapy that can treat sepsis-induced
immunoparalysis. In the latter case, ASA may have a broader indication as an immunomodulating
agent. Taken together, ASA might be a promising, cheap, well-known, and globally available
agent to reduce the incidence of secondary infections and improve patient outcome in sepsis.
Objective:
- To determine whether acetylsalicylic acid treatment can reverse endotoxin tolerance,
which is expressed as a decrease in pro-inflammatory cytokine levels between the first
and second endotoxin challenge.
- To determine whether acetylsalicylic acid prophylaxis can prevent endotoxin tolerance,
which is expressed as a decrease in pro-inflammatory cytokine levels between the first
and second endotoxin challenge.
Study design:
Double-blind randomized placebo-controlled pilot study in 30 healthy male volunteers during
repeated experimental endotoxemia. All subjects will receive a 14 day course of study
medication (low-dose ASA or placebo) and undergo experimental endotoxemia (lipopolysacharide
(LPS), E.Coli type O113) on day 7 and on day 14. LPS is administrated using an initial bolus
of 1ng/kg followed by continuous infusion at 1ng/kg/hr during 3 hours.
Subjects are randomized in three study arms:
1. Treatment group: 7 days placebo / first endotoxemia / 7 days ASA 80 mg (loading dose on
first day of 160mg) / second endotoxemia
2. Prophylaxis group: 7 days ASA 80 mg (loading dose on first day of 160mg) / first
endotoxemia / 7 days ASA 80 mg / second endotoxemia
3. Placebo group: 7 days placebo / first endotoxemia / 7 days placebo / second endotoxemia
n/a
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