Ethnic Differences in the Inflammatory Response in Systemic Inflammation - Full Text View

Sponsored by:	Medical University of Vienna
Information provided by:	Medical University of Vienna
ClinicalTrials.gov Identifier:	NCT00284869

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 I

Study Type:	Interventional
Study Design:	Educational/Counseling/Training, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

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

Additional Information:

Department Homepage This link exits the ClinicalTrials.gov site

Publications:

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.

Study ID Numbers:	EK255/2005
Study First Received:	January 31, 2006
Last Updated:	September 11, 2006
ClinicalTrials.gov Identifier:	NCT00284869 History of Changes
Health Authority:	Austria: Federal Ministry for Health and Women

Keywords provided by Medical University of Vienna:

LPS
ethnicity
neutrophils
TNF

Study placed in the following topic categories:

Systemic Inflammatory Response Syndrome
Sepsis
Bacteremia

Endotoxemia
Toxemia
Inflammation

Additional relevant MeSH terms:

Systemic Inflammatory Response Syndrome
Sepsis
Pathologic Processes
Bacteremia

Endotoxemia
Infection
Toxemia
Inflammation

ClinicalTrials.gov processed this record on August 30, 2009