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Ethnic Differences in the Inflammatory Response in Systemic Inflammation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00284869
Recruitment Status : Completed
First Posted : February 1, 2006
Last Update Posted : September 13, 2006
Sponsor:
Information provided by:
Medical University of Vienna

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

Condition or disease Intervention/treatment Phase
Endotoxemia Drug: LPS Phase 1

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 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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Educational/Counseling/Training
Official Title: Ethnic Differences in the Inflammatory Response in Systemic Inflammation
Study Start Date : January 2006
Study Completion Date : April 2006



Primary Outcome Measures :
  1. neutrophil counts
  2. IL-8
  3. G-CSF

Secondary Outcome Measures :
  1. various inflammation and coagulation parameters
  2. Platelets
  3. Adverse events


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00284869


Locations
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Austria
Medical University of Vienna, Dept. of Clinical Pharmacology
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
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Principal Investigator: Christa Firbas, MD Medical University of Vienna, Department of Clinical Pharmacology
Publications:
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ClinicalTrials.gov Identifier: NCT00284869    
Other Study ID Numbers: EK255/2005
First Posted: February 1, 2006    Key Record Dates
Last Update Posted: September 13, 2006
Last Verified: September 2006
Keywords provided by Medical University of Vienna:
LPS
ethnicity
neutrophils
TNF
Additional relevant MeSH terms:
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Endotoxemia
Inflammation
Pathologic Processes
Bacteremia
Sepsis
Infection
Toxemia
Systemic Inflammatory Response Syndrome