Ethnic Differences in the Inflammatory Response in Systemic Inflammation

Medical University of Vienna

Status and phase

Completed

Phase 1

Conditions

Endotoxemia

Treatments

Drug: LPS

Study type

Interventional

Funder types

Other

Identifiers

NCT00284869

EK255/2005

Details and patient eligibility

About

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

Full 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.

Sex

Male

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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