The Effects of Epinephrine in Endotoxemia in Normal Volunteers - Full Text View

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

Drug Information available for: Sodium chloride Epinephrine Epinephrine bitartrate Chlorides

U.S. FDA Resources

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

Further study details as provided by University of Medicine and Dentistry New Jersey:

Primary Outcome Measures:

Physiological, Hematological, Immunological Responses [ Time Frame: 0.5-24 hrs post Endotoxin administration ] [ Designated as safety issue: No ]

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)
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

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.

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00753402

Contacts

Contact: Susette M Coyle, RN	732-235-8143	coylesu@umdnj.edu
Contact: Marie A Macor, RN	732-235-8143	macorma@umdnj.edu

Locations

United States, New Jersey
UMDNJ-RWJMS	Recruiting
New Brunswick, New Jersey, United States, 08901

Sponsors and Collaborators

University of Medicine and Dentistry New Jersey

Investigators

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
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Systemic Inflammatory Response Syndrome
Sepsis
Bacteremia
Endotoxemia

Epinephrine
Toxemia
Inflammation

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Adrenergic alpha-Agonists
Adrenergic beta-Agonists
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Sympathomimetics
Physiological Effects of Drugs
Anti-Asthmatic Agents
Cardiovascular Agents

Infection
Pharmacologic Actions
Adrenergic Agonists
Pathologic Processes
Mydriatics
Autonomic Agents
Therapeutic Uses
Vasoconstrictor Agents
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 16, 2009