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The Effects of Hydrocortisone in Endotoxemia in Normal Volunteers

Information source: Rutgers, The State University of New Jersey
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Infections

Intervention: Endotoxin, Lipopolysaccharide, LPS (Biological); Endotoxin, Lipopolysaccharide, LPS /Epinephrine (Biological); Placebo (Biological); Hydrocortisone (Biological)

Phase: Phase 1

Status: Completed

Sponsored by: Rutgers, The State University of New Jersey

Official(s) and/or principal investigator(s):
Siobhan Corbett, MD, Principal Investigator, Affiliation: Rutgers-RWJMS

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.

Clinical Details

Official title: The Effects of Hydrocortisone in Endotoxemia in Normal Volunteers

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Primary outcome: Physiological, Hematological, Immunological Responses

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.

Eligibility

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Rutgers-RWJMS, New Brunswick, New Jersey 08901, United States
Additional Information

Starting date: February 2010
Last updated: May 20, 2014

Page last updated: August 23, 2015

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