Pathophysiology and Clinical Relevance of Endotoxin Tolerance in Humans
NCT ID: NCT00246714
Last Updated: 2008-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
16 participants
INTERVENTIONAL
2005-10-31
2007-12-31
Brief Summary
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Besides a diminished cytokine response, an increased production of leucocytes in the bone marrow and an increased phagocytosis after pre-treatment with endotoxin is seen. The combination of these factors: diminished systemic inflammatory response and increased cellular immunity makes that endotoxin tolerance is a useful tool for preventing the complications after an excessive inflammatory response.
Further, the presence of cross-tolerance has also been shown: Endotoxin tolerant mice survive more after induction of a normally lethal fungal infection. Endotoxin tolerance is also protective for ischemia/reperfusion injury in kidneys, heart and liver. Little data is known about endotoxin tolerance in human.
The purpose of this study is to induce a state of tolerance through 2 different administration schedules and monitor the effect of tolerance on pro- and anti-inflammatory cytokines, other inflammatory parameters and different proteins involved in the signalling pathway. The effects of tolerance on vascular reactivity will be determined. Finally, the effect of tolerance on ischemia-reperfusion injury will be investigated.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Interventions
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repeated injections of endotoxin during 5 days
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* tendency towards fainting
* BMI \< 18 kg/m2
18 Years
35 Years
MALE
Yes
Sponsors
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Radboud University Medical Center
OTHER
Responsible Party
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Radboud University Medical Centre
Principal Investigators
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Peter Pickkers, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Radboud University Nijmegen Medical Center
Locations
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Radboud University Nijmegen Medical Center
Nijmegen, Gelderland, Netherlands
Countries
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Other Identifiers
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PP03
Identifier Type: -
Identifier Source: org_study_id