Status:
COMPLETED
Ethnic Differences in the Inflammatory Response in Systemic Inflammation
Lead Sponsor:
Medical University of Vienna
Conditions:
Endotoxemia
Eligibility:
MALE
18-40 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to investigate putative ethnic differences in the proinflammatory response in human endotoxemia.
Detailed Description
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 dispar...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
End Date :
April 1 2006
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00284869
Start Date
January 1 2006
End Date
April 1 2006
Last Update
September 13 2006
Active Locations (1)
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1
Medical University of Vienna, Dept. of Clinical Pharmacology
Vienna, Vienna, Austria, 1090