NCT01064986

The Effects of Hydrocortisone in Endotoxemia in Normal Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Infections

Interventions

Type	Name	Description
BIOLOGICAL	Endotoxin, Lipopolysaccharide, LPS	Clinical Center Reference Endotoxin, lot 2, sterile saline, 1 ng/kg, bolus IV administration (\~5 minutes)
BIOLOGICAL	Endotoxin, Lipopolysaccharide, LPS /Epinephrine	Clinical Center Reference Endotoxin, lot 2, sterile saline, 1 ng/kg, continuous IV administration (Hydrocortisone 3mcg/kg/min)
BIOLOGICAL	Placebo	Saline vehicle (placebo)
BIOLOGICAL	Hydrocortisone	Hydrocortisone

Timeline

• Start date: 2010-02-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2010-02-09
• Last updated: 2014-05-22

Locations

1 site across 1 country: United States