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| Sponsored by: |
University of Medicine and Dentistry New Jersey |
|---|---|
| Information provided by: | University of Medicine and Dentistry New Jersey |
| ClinicalTrials.gov Identifier: | NCT00753402 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Immune System |
Biological: Endotoxin, Lipopolysaccharide, LPS Biological: Endotoxin, Lipopolysaccharide, LPS /Epinephrine |
Phase I |
| Study Type: | Interventional |
| Study Design: | Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment |
| Official Title: | The Effects of Epinephrine in Endotoxemia in Normal Volunteers |
| Estimated Enrollment: | 60 |
| Study Start Date: | October 2000 |
| Estimated Study Completion Date: | October 2011 |
| Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Placebo Comparator
IV Endotoxin plus saline vehicle (placebo)
|
Biological: Endotoxin, Lipopolysaccharide, LPS
Clinical Center Reference Endotoxin, lot 2, sterile saline, 2 ng/kg, bolus IV administration (~5 minutes)
|
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B: Active Comparator
IV Endotoxin plus IV epinephrine
|
Biological: Endotoxin, Lipopolysaccharide, LPS /Epinephrine
Clinical Center Reference Endotoxin, lot 2, sterile saline, 2 ng/kg, bolus IV administration (~5 minutes/Epinephrine 30mcg/kg/min
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Susette M Coyle, RN | 732-235-8143 | coylesu@umdnj.edu |
| Contact: Marie A Macor, RN | 732-235-8143 | macorma@umdnj.edu |
| United States, New Jersey | |
| UMDNJ-RWJMS | Recruiting |
| New Brunswick, New Jersey, United States, 08901 | |
| Principal Investigator: | Stephen F Lowry, MD | UMDNJ-RWJMS |
More Information
| Responsible Party: | UMDNJ-RWJMS ( Stephen F. Lowry, MD ) |
| Study ID Numbers: | 0220003283, NIH/DHHS GM34695 |
| Study First Received: | September 15, 2008 |
| Last Updated: | September 21, 2008 |
| ClinicalTrials.gov Identifier: | NCT00753402 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Systemic Inflammatory Response Syndrome Neurotransmitter Agents Adrenergic alpha-Agonists Adrenergic beta-Agonists Adrenergic Agents Anti-Asthmatic Agents Bacteremia Cardiovascular Agents Adrenergic Agonists |
Toxemia Inflammation Sepsis Mydriatics Vasoconstrictor Agents Endotoxemia Peripheral Nervous System Agents Epinephrine Bronchodilator Agents |
|
Respiratory System Agents Neurotransmitter Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Infection Adrenergic Agonists Pathologic Processes Therapeutic Uses Vasoconstrictor Agents Endotoxemia Epinephrine Systemic Inflammatory Response Syndrome Adrenergic alpha-Agonists |
Adrenergic beta-Agonists Sympathomimetics Anti-Asthmatic Agents Bacteremia Cardiovascular Agents Toxemia Pharmacologic Actions Inflammation Sepsis Mydriatics Autonomic Agents Peripheral Nervous System Agents Bronchodilator Agents |
