The Effects of Hydrocortisone in Endotoxemia in Normal Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2012-12-31

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.

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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.

Conditions

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Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

IV Endotoxin plus saline vehicle (placebo)

Group Type PLACEBO_COMPARATOR

Endotoxin, Lipopolysaccharide, LPS

Intervention Type BIOLOGICAL

Clinical Center Reference Endotoxin, lot 2, sterile saline, 1 ng/kg, bolus IV administration (\~5 minutes)

Placebo

Intervention Type BIOLOGICAL

Saline vehicle (placebo)

B

IV Endotoxin plus IV hydrocortisone

Group Type ACTIVE_COMPARATOR

Endotoxin, Lipopolysaccharide, LPS /Epinephrine

Intervention Type BIOLOGICAL

Clinical Center Reference Endotoxin, lot 2, sterile saline, 1 ng/kg, continuous IV administration (Hydrocortisone 3mcg/kg/min)

Hydrocortisone

Intervention Type BIOLOGICAL

Hydrocortisone

Interventions

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Endotoxin, Lipopolysaccharide, LPS

Clinical Center Reference Endotoxin, lot 2, sterile saline, 1 ng/kg, bolus IV administration (\~5 minutes)

Intervention Type BIOLOGICAL

Endotoxin, Lipopolysaccharide, LPS /Epinephrine

Clinical Center Reference Endotoxin, lot 2, sterile saline, 1 ng/kg, continuous IV administration (Hydrocortisone 3mcg/kg/min)

Intervention Type BIOLOGICAL

Placebo

Saline vehicle (placebo)

Intervention Type BIOLOGICAL

Hydrocortisone

Intervention Type BIOLOGICAL

Other Intervention Names

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Sodium Chloride Solution Solu-Cortef

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes