Cortisol Control of Human Inflammatory Responses to Endotoxin - Full Text View

Sponsors and Collaborators:	Dartmouth-Hitchcock Medical Center National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:	NCT00396344

Purpose

The purpose of the research is to study a common and dangerous medical condition called 'septic shock' that often occurs in critically ill patients. In order to learn about septic shock in humans, we will administer a substance called 'endotoxin' to participants in this study. Endotoxin causes a temporary period of inflammation in the human body, a brief 'virtual' infection. This is an established method for the investigation of inflammation properties. We are interested in how the natural hormone, cortisol, can affect the human response to endotoxin. We know that when cortisol is given at the same time as endotoxin it can decrease the inflammation that occurs due to endotoxin. In this study we will test whether or not cortisol, when given the day before the endotoxin, will work to change the inflammation that occurs due to endotoxin. In order to test this, two-thirds of the study participants will receive cortisol on the day before they receive the endotoxin and one-third of the study participants will receive a placebo (no medication) before the endotoxin.

Condition	Intervention
Sepsis	Other: Çontrol Drug: Hydrocortisone

MedlinePlus related topics: Sepsis

Drug Information available for: Hydrocortisone Cortisol 21-phosphate Cortisol succinate Hydrocortamate Hydrocortisone 21-sodium succinate Hydrocortisone acetate Hydrocortisone cypionate Hydrocortisone hemisuccinate Proctofoam-HC Sodium chloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment
Official Title:	The Effect of Glucocorticoid Pre-Treatment on the Systemic Cytokine Response to Endotoxin in Human Volunteers

Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:

Plasma cytokine responses to in vivo endotoxin administration [ Time Frame: 4 Days ]

Secondary Outcome Measures:

Plasma acute phase protein response [ Time Frame: 4 Days ]
Clinical response [ Time Frame: 8 Hours ]

Estimated Enrollment:	36
Study Start Date:	October 2006
Study Completion Date:	November 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Saline control	Other: Çontrol Intravenous saline
2: Experimental	Drug: Hydrocortisone Intravenous stress dose of hydrocortisone
3: Experimental	Drug: Hydrocortisone Intravenous pharmacologic hydrocortisone

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

18 < age < 55
Weight > 50 kg
The participant is healthy, without known or suspected medical illness following routine history and physical examination and is expected to easily tolerate the clinical effects of endotoxin.
The participant does not take any regularly scheduled medication other than thyroid replacement therapy, birth control pills, or estrogenic hormone replacement therapy.

Exclusion Criteria:

History of chronic disease of any kind such as diabetes, heart disease, cancer, HIV infection, hypertension, asthma, etc.
History of chronic medication use other than hormone therapy as above
History of recent acute illness within 30 days prior to study
Inability to provide informed consent
History of recent exposure to drugs known to alter immune function including steroids or recent infection (< 3 months)
Pregnancy
History of known risk factors for HIV infection (recent multiple partners, sexually transmitted disease and unprotected sex; intravenous drug use; blood transfusion before 1985)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00396344

Locations

United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756

Sponsors and Collaborators

Dartmouth-Hitchcock Medical Center

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Principal Investigator:

Mark P Yeager, MD

Dartmouth-Hitchcock Medical Center

More Information

Study ID Numbers:	CPHS#20361, NIH#AIO51547
Study First Received:	November 3, 2006
Last Updated:	May 6, 2008
ClinicalTrials.gov Identifier:	NCT00396344
Health Authority:	United States: Food and Drug Administration

Keywords provided by Dartmouth-Hitchcock Medical Center:

Systemic sepsis

Study placed in the following topic categories:

Systemic Inflammatory Response Syndrome
Sepsis
Hydrocortisone

Cortisol succinate
Hydrocortisone acetate
Inflammation

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Pathologic Processes
Therapeutic Uses
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009