The Effects of Hydrocortisone in Endotoxemia in Normal Volunteers

Study Overview
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Brief Summary
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Corticosteroids are substances produced by the adrenal gland to help the body fight against infection or injury. Hydrocortisone is a man-made form of this substance. 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 give hydrocortisone before and after Endotoxin to determine if this medication can prevent or relieve any of the symptoms caused by the Endotoxin.

Detailed Description
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The body's immune response to injury otr infection is very complex. Immune cell activity, the release of specific mediators (such as proteins), genetics (Deoxyribonucleic acid or DNA) and/or the body's instructions for making proteins (Ribonucleic Acid or RNA) may effect the body's clinical response to a stress such as an infection.Hydrocortisone is a substance produced by the body (in the adrenal gland)in response to stress such as infection or injury. 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 give hydrocortisone before and/or after endotoxin to determine if this medication can prevent or relieve any of the symptoms caused by endotoxin.In addition, this study may determine whether any of the above(proteins,DNA,RNA,etc.) correlate with or affect the body's response to hydrocortisone and/or endotoxin. This will enable the investigator to better understand whether treatment with this substance can alter the body's immune response.

Official Title
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The Effects of Hydrocortisone in Endotoxemia in Normal Volunteers

Conditions
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Infections

Intervention / Treatment
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* Biological: Endotoxin, Lipopolysaccharide, LPS
* Biological: Endotoxin, Lipopolysaccharide, LPS /Epinephrine
* Biological: Placebo
* Biological: Hydrocortisone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: General good health as demonstrated by medical history, physical& laboratory tests Age between 18 and 40 years Written informed consent prior to the performance of any study related procedures Exclusion Criteria: History of cancer, rheumatoid arthritis, or immunological, renal, hepatic, endocrine, neurologic, heart disease or hypertension Any medication taken in past 48 hrs (except birth control) Recent history of alcohol or drug abuse Unable to provide written informed consent Exposure to any experimental agent or procedure within 30 days of study Pregnant or breast-feeding

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: A<br>IV Endotoxin plus saline vehicle (placebo) | Biological: Endotoxin, Lipopolysaccharide, LPS<br>* Clinical Center Reference Endotoxin, lot 2, sterile saline, 1 ng/kg, bolus IV administration ( 5 minutes)<br>* Other names: Sodium Chloride Solution;Biological: Placebo<br>* Saline vehicle (placebo)<br>|
| Active Comparator: B<br>IV Endotoxin plus IV hydrocortisone | Biological: Endotoxin, Lipopolysaccharide, LPS /Epinephrine<br>* Clinical Center Reference Endotoxin, lot 2, sterile saline, 1 ng/kg, continuous IV administration (Hydrocortisone 3mcg/kg/min)<br>* Other names: Solu-Cortef;Biological: Hydrocortisone<br>* Hydrocortisone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physiological, Hematological, Immunological Responses |  | 0.5-24 hrs post Endotoxin administration | 

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