Inflammation and the Host Response to Injury (In Healthy Volunteers)

Study Overview
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Brief Summary
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The body's immune response to injury or infection is very complex.Endotoxin is a man-made substance, which causes the body to mimic sickness (fever,chills, and achiness)for a few hours. This study is designed to determine whether certain proteins, genetics, or heart rate variability change affects the body's response to endotoxin.

Detailed Description
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The body's immune response to injury or infection is very complex.Immune cell activity, the release of specific mediators(such as proteins, genetics(Deoxyribonucleic acid or DNA), the body's instructions for making proteins (Ribonucleic Acid or RNA) and heart rate variability (HRV,the intervals between heartbeats) may affect the body's clinical response to stress such as infection.Endotoxin is a man-made substance, which causes the body to mimic sickness (fever,chills, and achiness)for a few hours. This study is designed to determine whether any of the above (proteins,genetics,or HRV, etc.) correlate with or affect the body's response to endotoxin.This will enable the investigator to better understand the mechanisms involved in the immune response as well as potential therapeutic strategies to improve outcomes in patients.

Official Title
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Inflammation and the Host Response to Injury (In Healthy Volunteers)

Conditions
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Immune System

Intervention / Treatment
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* Biological: Endotoxin, Lipopolysaccharide, LPS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Good general health as demonstrated by medical history,physical exam, and laboratory tests within 6 weeks of study. Written informed consent prior to the performance of any study related procedure. Exclusion Criteria: History of cancer, rheumatoid arthritis, or immunological, renal, hepatic, endocrine, neurologic, heart disease or hypertension Recent history of alcohol or drug abuse Mental capacity limited to the extent that the subject cannot provide written informed consent or information regarding treatment-emergent adverse events and/or tolerance of study medication and/or study procedures Exposure to any experimental agent or procedure within 30 days of study Pregnancy or breast feeding Prior exposure to endotoxin in an experimental setting -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Time points after IV Endotoxin administration compared to baseline (immediately before Endotoxin administration). | Biological: Endotoxin, Lipopolysaccharide, LPS<br>* Clinical Center Reference Endotoxin, lot 2, sterile saline, 2 ng/kg, bolus IV administration ( 5 minutes)<br>* Other names: Sodium Chloride Solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physiological, Hematological, Immunological Responses |  | .5-24 hours after Endotoxin administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Immune System