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Ethnic Differences in the Inflammatory Response in Systemic Inflammation

Primary Purpose

Endotoxemia

Status
Completed
Phase
Phase 1
Locations
Austria
Study Type
Interventional
Intervention
LPS
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional educational/counseling/training trial for Endotoxemia focused on measuring LPS, ethnicity, neutrophils, TNF

Eligibility Criteria

18 Years - 40 Years (Adult)MaleAccepts 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

Sites / Locations

  • Medical University of Vienna, Dept. of Clinical Pharmacology

Outcomes

Primary Outcome Measures

neutrophil counts
IL-8
G-CSF

Secondary Outcome Measures

various inflammation and coagulation parameters
Platelets
Adverse events

Full Information

First Posted
January 31, 2006
Last Updated
September 11, 2006
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT00284869
Brief Title
Ethnic Differences in the Inflammatory Response in Systemic Inflammation
Official Title
Ethnic Differences in the Inflammatory Response in Systemic Inflammation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Medical University of Vienna

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endotoxemia
Keywords
LPS, ethnicity, neutrophils, TNF

7. Study Design

Primary Purpose
Educational/Counseling/Training
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
LPS
Primary Outcome Measure Information:
Title
neutrophil counts
Title
IL-8
Title
G-CSF
Secondary Outcome Measure Information:
Title
various inflammation and coagulation parameters
Title
Platelets
Title
Adverse events

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christa Firbas, MD
Organizational Affiliation
Medical University of Vienna, Department of Clinical Pharmacology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna, Dept. of Clinical Pharmacology
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

Citations:
PubMed Identifier
16413239
Citation
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.
Results Reference
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Ethnic Differences in the Inflammatory Response in Systemic Inflammation

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