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

Tracking Information

First Received Date ^ICMJE

February 5, 2010

Last Updated Date

February 28, 2013

Start Date ^ICMJE

February 2010

Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01064986 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

The Effects of Hydrocortisone in Endotoxemia in Normal Volunteers

Official Title ^ICMJE

The Effects of Hydrocortisone in Endotoxemia in Normal Volunteers

Brief 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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Infections

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2012

Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 40 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01064986

Other Study ID Numbers ^ICMJE

0220070126, NIH/DHHS

Has Data Monitoring Committee

Responsible Party

University of Medicine and Dentistry New Jersey

Study Sponsor ^ICMJE

University of Medicine and Dentistry New Jersey

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Stephen F Lowry, MD

UMDNJ-RWJMS

Information Provided By

University of Medicine and Dentistry New Jersey

Verification Date

February 2013

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

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