The Effects of Hydrocortisone in Endotoxemia in Normal Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT01064986
First received: February 5, 2010
Last updated: May 20, 2014
Last verified: May 2014

February 5, 2010
May 20, 2014
February 2010
December 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 NCT01064986 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Effects of Hydrocortisone in Endotoxemia in Normal Volunteers
The Effects of Hydrocortisone in Endotoxemia in Normal Volunteers

Corticosteroids are substances produced by the adrenal gland to help the body fight against infection or injury. Hydrocortisone is a man-made form of this substance. 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 hydrocortisone before and after Endotoxin to determine if this medication can prevent or relieve any of the symptoms caused by the 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.Hydrocortisone 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 hydrocortisone 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 hydrocortisone 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)
Infections
  • Biological: Endotoxin, Lipopolysaccharide, LPS
    Clinical Center Reference Endotoxin, lot 2, sterile saline, 1 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, 1 ng/kg, continuous IV administration (Hydrocortisone 3mcg/kg/min)
    Other Name: Solu-Cortef
  • Biological: Placebo
    Saline vehicle (placebo)
  • Biological: Hydrocortisone
    Hydrocortisone
  • Placebo Comparator: A
    IV Endotoxin plus saline vehicle (placebo)
    Interventions:
    • Biological: Endotoxin, Lipopolysaccharide, LPS
    • Biological: Placebo
  • Active Comparator: B
    IV Endotoxin plus IV hydrocortisone
    Interventions:
    • Biological: Endotoxin, Lipopolysaccharide, LPS /Epinephrine
    • Biological: Hydrocortisone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
December 2012
December 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
 
NCT01064986
0220070126, NIH/DHHS
No
Rutgers, The State University of New Jersey
Rutgers, The State University of New Jersey
Not Provided
Principal Investigator: Siobhan Corbett, MD Rutgers-RWJMS
Rutgers, The State University of New Jersey
May 2014

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