Ethnic Differences in the Inflammatory Response in Systemic Inflammation

Study Overview
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Brief Summary
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The purpose of this study is to investigate putative ethnic differences in the proinflammatory response in human endotoxemia.

Detailed Description
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Recent data show that there are significant disparities among genders and races in the incidence of sepsis. While men are consistently more likely to have sepsis than women, the apparent racial disparities are even more striking, approaching a doubling of the risk for sepsis among Afro-Americans. Most prominent is the risk among black men, the group in which sepsis occurs at the youngest age and results in the most deaths. Potential mechanisms for heterogeneous susceptibility to sepsis include genetic differences, which have been explored according to sex but not according to race, and other social and clinical factors. The goal of this study is to explore whether proinflammatory and procoagulant responses in a well standardised inflammation model are comparable in healthy Caucasian and African volunteers.

Official Title
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Ethnic Differences in the Inflammatory Response in Systemic Inflammation

Conditions
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Endotoxemia

Intervention / Treatment
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* Drug: LPS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent obtained before any trial-related activities. (Trial activities are any procedure that would not have been performed during normal management of the subject). Men aged >18 and <40 years Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant Exclusion Criteria: Treatment with an investigational drug within three weeks prior to this trial Participation in an LPS trial within the last 6 weeks Hereditary deficiency of protein C or S, or a mutation of FV (Leiden), or any other known abnormality affecting coagulation, fibrinolysis or platelet function History of cardiovascular disease Liver or kidney dysfunction Regular use of medication or alcohol abuse Use of any medication within three weeks prior to the first trial day Symptoms of a clinically relevant illness in the 3 weeks before the first trial day Excessive sporting activities Weight over 95 kg

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Educational/Counseling/Training
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: LPS|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neutrophil counts |  |  | 
| IL-8 |  |  | 
| G-CSF |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| various inflammation and coagulation parameters |  |  | 
| Platelets |  |  | 
| Adverse events |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LPS, ethnicity, neutrophils, TNF