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The Effects of Hydrocortisone in Endotoxemia in Normal Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:
NCT01064986
First received: February 5, 2010
Last updated: February 28, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Infections
 Biological: Endotoxin, Lipopolysaccharide, LPS
Biological: Endotoxin, Lipopolysaccharide, LPS /Epinephrine
Biological: Placebo
Biological: Hydrocortisone
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: The Effects of Hydrocortisone in Endotoxemia in Normal Volunteers

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Enrollment: 12
Study Start Date: February 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: A
IV Endotoxin plus saline vehicle (placebo)
 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: Placebo
Saline vehicle (placebo)
Active Comparator: B
IV Endotoxin plus IV hydrocortisone
 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: Hydrocortisone
Hydrocortisone

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.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.

  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: NCT01064986

Locations
United States, New Jersey
Umdnj-Rwjms
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

No publications provided

Responsible Party: University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier: NCT01064986     History of Changes
Other Study ID Numbers: 0220070126, NIH/DHHS
Study First Received: February 5, 2010
Last Updated: February 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Medicine and Dentistry New Jersey:
Immune System

Additional relevant MeSH terms:
Endotoxemia
Bacteremia
Sepsis
Infection
Toxemia
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Epinephrine
Epinephryl borate
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone
Hydrocortisone-17-butyrate
 Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Adrenergic alpha-Agonists

ClinicalTrials.gov processed this record on May 22, 2013