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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00753402
Other study ID # 0220003283
Secondary ID
Status Completed
Phase Phase 1
First received September 15, 2008
Last updated May 26, 2015
Start date February 2012
Est. completion date February 2012

Study information

Verified date May 2015
Source Rutgers, The State University of New Jersey
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 37
Est. completion date February 2012
Est. primary completion date February 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Biological:
Endotoxin, Lipopolysaccharide, LPS
Clinical Center Reference Endotoxin, lot 2, sterile saline, 2 ng/kg, bolus IV administration (~5 minutes)
Endotoxin, Epinephrine
Clinical Center Reference Endotoxin, lot 2, sterile saline, 2 ng/kg, bolus IV administration (~5 minutes/Epinephrine 30mcg/kg/min

Locations

Country Name City State
United States Rutgers-RWJMS New Brunswick New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Physiological, Hematological, Immunological Responses 0.5-24 hrs post Endotoxin administration
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