Ethnic Differences in the Inflammatory Response in Systemic Inflammation

Endotoxemia Clinical Trial

Official title:

Ethnic Differences in the Inflammatory Response in Systemic Inflammation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00284869
• Other study ID #: EK255/2005
• Status: Completed
• Phase: Phase 1
• First received: January 31, 2006
• Last updated: September 11, 2006
• Start date: January 2006
• Est. completion date: April 2006

Study information

• Verified date: September 2006
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and Women
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

• Endotoxemia

Intervention

Drug:
• LPS

Locations

Country	Name	City	State
Austria	Medical University of Vienna, Dept. of Clinical Pharmacology	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	neutrophil counts
Primary	IL-8
Primary	G-CSF
Secondary	various inflammation and coagulation parameters
Secondary	Platelets
Secondary	Adverse events