LPS in Endotoxemia - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Endotoxemia

Intervention / Treatment

Drug: LPS

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.

Study Type

Interventional

Enrollment

32

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Austria
- - Vienna, Austria, 1090
    - Medical University of Vienna, Dept. of Clinical Pharmacology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Educational/Counseling/Training
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
neutrophil counts
IL-8
G-CSF

Secondary Outcome Measures

Outcome Measure
Adverse events
various inflammation and coagulation parameters
Platelets

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

Principal Investigator: Christa Firbas, MD, Medical University of Vienna, Department of Clinical Pharmacology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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. doi: 10.1016/j.clpt.2005.10.003.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Study Completion

April 1, 2006

Study Registration Dates

First Submitted

January 31, 2006

First Submitted That Met QC Criteria