Ethnic Differences in the Inflammatory Response in Systemic Inflammation

NCT ID: NCT00284869

Last Updated: 2006-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2006-04-30

Brief Summary

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

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.

Conditions

Endotoxemia

Keywords

LPS; ethnicity; neutrophils; TNF

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: ECT
• Blinding Strategy: NONE

Interventions

LPS

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Principal Investigators

Christa Firbas, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna, Department of Clinical Pharmacology

Locations

Medical University of Vienna, Dept. of Clinical Pharmacology

Vienna, Vienna, Austria

Countries

Austria

References

Leitner JM, Firbas C, Mayr FB, Reiter RA, Steinlechner B, Jilma B. Recombinant human antithrombin inhibits thrombin formation and interleukin 6 release in human endotoxemia. Clin Pharmacol Ther. 2006 Jan;79(1):23-34. doi: 10.1016/j.clpt.2005.10.003.

Reference Type: BACKGROUND

PMID: 16413239 (View on PubMed)

Other Identifiers

EK255/2005

Identifier Type: -

Identifier Source: org_study_id