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Ethnic Differences in the Inflammatory Response in Systemic Inflammation

This study has been completed.
Information provided by:
Medical University of Vienna Identifier:
First received: January 31, 2006
Last updated: September 11, 2006
Last verified: September 2006
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
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
Official Title: Ethnic Differences in the Inflammatory Response in Systemic Inflammation

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • neutrophil counts
  • IL-8
  • G-CSF

Secondary Outcome Measures:
  • various inflammation and coagulation parameters
  • Platelets
  • Adverse events

Estimated Enrollment: 32
Study Start Date: January 2006
Estimated Study Completion Date: April 2006
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.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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
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Please refer to this study by its identifier: NCT00284869

Medical University of Vienna, Dept. of Clinical Pharmacology
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Principal Investigator: Christa Firbas, MD Medical University of Vienna, Department of Clinical Pharmacology
  More Information

Publications: Identifier: NCT00284869     History of Changes
Other Study ID Numbers: EK255/2005
Study First Received: January 31, 2006
Last Updated: September 11, 2006

Keywords provided by Medical University of Vienna:

Additional relevant MeSH terms:
Pathologic Processes
Systemic Inflammatory Response Syndrome processed this record on June 23, 2017