The Effects of Hydrocortisone in Endotoxemia in Normal Volunteers

NCT01064986 | Completed Phase 1

• 2 other identifiers: 0220070126NIH/DHHS
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Infections

Keywords

Immune System

Outcome Measures

Primary Outcomes (1)

• Physiological, Hematological, Immunological Responses

  0.5-24 hrs post Endotoxin administration

Study Arms (2)

A

PLACEBO COMPARATOR

IV Endotoxin plus saline vehicle (placebo)

Biological: Endotoxin, Lipopolysaccharide, LPS; Biological: Placebo

B

ACTIVE COMPARATOR

IV Endotoxin plus IV hydrocortisone

Biological: Endotoxin, Lipopolysaccharide, LPS /Epinephrine; Biological: Hydrocortisone

Interventions

Endotoxin, Lipopolysaccharide, LPS BIOLOGICAL

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

Also known as: Sodium Chloride Solution

A

Endotoxin, Lipopolysaccharide, LPS /Epinephrine BIOLOGICAL

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

Also known as: Solu-Cortef

B

Placebo BIOLOGICAL

Saline vehicle (placebo)

A

Hydrocortisone BIOLOGICAL

Hydrocortisone

B

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Rutgers-RWJMS

New Brunswick, New Jersey, 08901, United States

Location

MeSH Terms

Conditions

Infections

Interventions

Endotoxins; Lipopolysaccharides; Sodium Chloride; Epinephrine; hydrocortisone hemisuccinate; Hydrocortisone

Intervention Hierarchy (Ancestors)

Bacterial Toxins; Toxins, Biological; Biological Factors; Glycoconjugates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Lipids; Antigens, Bacterial; Antigens; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Study Officials

• Siobhan Corbett, MD

  Rutgers-RWJMS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2010
• First Posted: February 9, 2010
• Study Start: February 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 22, 2014

Record last verified: 2014-05

Locations

US (1)