The Effects of Hydrocortisone in Endotoxemia in Normal Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01064986

Enrollment

Registered

2010-02-09

Start date

2010-02-28

Completion date

2012-12-31

Last updated

2014-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infections

Keywords

Immune System

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.

Interventions

BIOLOGICALEndotoxin, Lipopolysaccharide, LPS

Clinical Center Reference Endotoxin, lot 2, sterile saline, 1 ng/kg, bolus IV administration (\ 5 minutes)

BIOLOGICALEndotoxin, Lipopolysaccharide, LPS /Epinephrine

Clinical Center Reference Endotoxin, lot 2, sterile saline, 1 ng/kg, continuous IV administration (Hydrocortisone 3mcg/kg/min)

BIOLOGICALPlacebo

Saline vehicle (placebo)

BIOLOGICALHydrocortisone

Hydrocortisone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Physiological, Hematological, Immunological Responses	0.5-24 hrs post Endotoxin administration

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026