Ethnic Differences in the Inflammatory Response in Systemic Inflammation

This study has been completed.
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00284869
First received: January 31, 2006
Last updated: September 11, 2006
Last verified: September 2006
  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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00284869

Locations
Austria
Medical University of Vienna, Dept. of Clinical Pharmacology
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
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 July 31, 2014