The Effects of Hydrocortisone in Endotoxemia in Normal Volunteers

Phase 1

Completed

• Conditions: Infections
• Interventions: Biological: Endotoxin, Lipopolysaccharide, LPS; Biological: Endotoxin, Lipopolysaccharide, LPS /Epinephrine; Biological: Placebo; Biological: Hydrocortisone

• Registration Number: NCT01064986
• Lead Sponsor: Rutgers, The State University of New Jersey

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-05
• Study First Submitted QC: 2010-02-08
• Study First Posted: 2010-02-09
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-20
• Last Update Posted: 2014-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Placebo	IV Endotoxin plus saline vehicle (placebo)
A	Endotoxin, Lipopolysaccharide, LPS	IV Endotoxin plus saline vehicle (placebo)
B	Endotoxin, Lipopolysaccharide, LPS /Epinephrine	IV Endotoxin plus IV hydrocortisone
B	Hydrocortisone	IV Endotoxin plus IV hydrocortisone

Primary Outcome Measures

Name	Time	Method
Physiological, Hematological, Immunological Responses	0.5-24 hrs post Endotoxin administration

Trial Locations

Locations (1)

Rutgers-RWJMS; 🇺🇸 New Brunswick, New Jersey, United States