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Completed

NCT Number: NCT00284869

Ethnic Differences in the Inflammatory Response in Systemic Inflammation

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

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Key information

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Medical University of Vienna, Dept. of Clinical Pharmacology

Vienna, State of Vienna, 1090, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LPS

Drug

Primary outcomes

  1. neutrophil counts

  2. IL-8

  3. G-CSF

Secondary outcomes

  1. various inflammation and coagulation parameters

  2. Platelets

  3. Adverse events

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Important dates

Study start
2006
Study completion
2006
First posted
Feb 1, 2006
Registry last updated
Sep 13, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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