The Effects of Hydrocortisone in Endotoxemia in Normal Volunteers

Infections Clinical Trial

Official title:

The Effects of Hydrocortisone in Endotoxemia in Normal Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01064986
• Other study ID #: 0220070126
• Secondary ID: NIH/DHHS
• Status: Completed
• Phase: Phase 1
• First received: February 5, 2010
• Last updated: May 20, 2014
• Start date: February 2010
• Est. completion date: December 2012

Study information

• Verified date: May 2014
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Endotoxemia
• Infections

Intervention

Biological:
• Endotoxin, Lipopolysaccharide, LPS
Clinical Center Reference Endotoxin, lot 2, sterile saline, 1 ng/kg, bolus IV administration (~5 minutes)
• Endotoxin, Lipopolysaccharide, LPS /Epinephrine
Clinical Center Reference Endotoxin, lot 2, sterile saline, 1 ng/kg, continuous IV administration (Hydrocortisone 3mcg/kg/min)
• Placebo
Saline vehicle (placebo)
• Hydrocortisone
Hydrocortisone

Locations

Country	Name	City	State
United States	Rutgers-RWJMS	New Brunswick	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physiological, Hematological, Immunological Responses		0.5-24 hrs post Endotoxin administration	No