Clinical trial NCT00284869: Ethnic Differences in the Inflammatory Response in Systemic Inflammation
Official title: Ethnic Differences in the Inflammatory Response in Systemic Inflammation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Endotoxemia
Keywords: LPS
ethnicity
neutrophils
TNF
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2006-02-01
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: ECT

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.

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

Primary outcomes:
measure: neutrophil counts
measure: IL-8
measure: G-CSF
Secondary outcomes:
measure: various inflammation and coagulation parameters
measure: Platelets
measure: Adverse events
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna, Dept. of Clinical Pharmacology
Study officials:
affiliation: Medical University of Vienna, Department of Clinical Pharmacology
name: Christa Firbas, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.