Immune System
Conditions
Brief summary
Epinephrine (adrenaline) 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 epinephrine before and/or after endotoxin to determine if this medication can prevent or relieve any of the symptoms caused by 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.Epinephrine (adrenaline) 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 epinephrine 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 epinephrine and/or endotoxin. This will enable the investigator to better understand whether treatment with this substance can alter the body's immune response.
Interventions
BIOLOGICALEndotoxin, Lipopolysaccharide, LPS
Clinical Center Reference Endotoxin, lot 2, sterile saline, 2 ng/kg, bolus IV administration (\ 5 minutes)
BIOLOGICALEndotoxin, Epinephrine
Clinical Center Reference Endotoxin, lot 2, sterile saline, 2 ng/kg, bolus IV administration (\ 5 minutes/Epinephrine 30mcg/kg/min
Sponsors
Rutgers, The State University of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Physiological, Hematological, Immunological Responses | 0.5-24 hrs post Endotoxin administration |
Countries
United States
Outcome results
None listed