Ethnic Differences in the Inflammatory Response in Systemic Inflammation
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Purpose
The purpose of this study is to investigate putative ethnic differences in the proinflammatory response in human endotoxemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Endotoxemia |
Drug: LPS |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Educational/Counseling/Training |
| Official Title: | Ethnic Differences in the Inflammatory Response in Systemic Inflammation |
- neutrophil counts
- IL-8
- G-CSF
- various inflammation and coagulation parameters
- Platelets
- Adverse events
| Estimated Enrollment: | 32 |
| Study Start Date: | January 2006 |
| Estimated Study Completion Date: | April 2006 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Austria | |
| Medical University of Vienna, Dept. of Clinical Pharmacology | |
| Vienna, Austria, 1090 | |
| Principal Investigator: | Christa Firbas, MD | Medical University of Vienna, Department of Clinical Pharmacology |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00284869 History of Changes |
| Other Study ID Numbers: | EK255/2005 |
| Study First Received: | January 31, 2006 |
| Last Updated: | September 11, 2006 |
| Health Authority: | Austria: Federal Ministry for Health and Women |
Keywords provided by Medical University of Vienna:
|
LPS ethnicity neutrophils TNF |
Additional relevant MeSH terms:
|
Inflammation Endotoxemia Pathologic Processes Bacteremia |
Sepsis Infection Toxemia Systemic Inflammatory Response Syndrome |
ClinicalTrials.gov processed this record on May 19, 2013