The Effects of Epinephrine in Endotoxemia in Normal Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier:
NCT00753402
First received: September 15, 2008
Last updated: February 28, 2013
Last verified: February 2013

September 15, 2008
February 28, 2013
February 2012
February 2012   (final data collection date for primary outcome measure)
Physiological, Hematological, Immunological Responses [ Time Frame: 0.5-24 hrs post Endotoxin administration ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00753402 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Effects of Epinephrine in Endotoxemia in Normal Volunteers
The Effects of Epinephrine in Endotoxemia in Normal Volunteers

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.

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.

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Immune System
  • Biological: Endotoxin, Lipopolysaccharide, LPS
    Clinical Center Reference Endotoxin, lot 2, sterile saline, 2 ng/kg, bolus IV administration (~5 minutes)
    Other Name: Sodium Chloride Solution
  • 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
    Other Name: Adrenaline Chloride
  • Placebo Comparator: A
    IV Endotoxin plus saline vehicle (placebo)
    Intervention: Biological: Endotoxin, Lipopolysaccharide, LPS
  • Active Comparator: B
    IV Endotoxin plus IV epinephrine
    Intervention: Biological: Endotoxin, Lipopolysaccharide, LPS /Epinephrine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
February 2012
February 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00753402
0220003283, NIH/DHHS GM34695
No
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
University of Medicine and Dentistry of New Jersey
Not Provided
Principal Investigator: Siobhan Corbett, MD UMDNJ-RWJMS
Rutgers, The State University of New Jersey
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP