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The Effects of Hydrocortisone in Endotoxemia in Normal Volunteers

NCT01064986 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2014-05-22

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

Endotoxin, Lipopolysaccharide, LPS

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

BIOLOGICAL

Endotoxin, Lipopolysaccharide, LPS /Epinephrine

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

BIOLOGICAL

Placebo

Saline vehicle (placebo)

BIOLOGICAL

Hydrocortisone

Hydrocortisone

Sponsors & Collaborators

  • Rutgers, The State University of New Jersey

    lead OTHER

Principal Investigators

  • Siobhan Corbett, MD · Rutgers-RWJMS

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01064986 on ClinicalTrials.gov