Cortisol Control of Human Inflammatory Responses to Endotoxin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00396344
Recruitment Status : Completed
First Posted : November 6, 2006
Last Update Posted : May 9, 2008
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:
Dartmouth-Hitchcock Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Sepsis Other: Çontrol Drug: Hydrocortisone Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: The Effect of Glucocorticoid Pre-Treatment on the Systemic Cytokine Response to Endotoxin in Human Volunteers
Study Start Date : October 2006
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Arm Intervention/treatment
Placebo Comparator: 1
Saline control
Other: Çontrol
Intravenous saline
Experimental: 2 Drug: Hydrocortisone
Intravenous stress dose of hydrocortisone
Experimental: 3 Drug: Hydrocortisone
Intravenous pharmacologic hydrocortisone

Primary Outcome Measures :
  1. Plasma cytokine responses to in vivo endotoxin administration [ Time Frame: 4 Days ]

Secondary Outcome Measures :
  1. Plasma acute phase protein response [ Time Frame: 4 Days ]
  2. Clinical response [ Time Frame: 8 Hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00396344

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)
Principal Investigator: Mark P Yeager, MD Dartmouth-Hitchcock Medical Center

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00396344     History of Changes
Other Study ID Numbers: CPHS#20361
First Posted: November 6, 2006    Key Record Dates
Last Update Posted: May 9, 2008
Last Verified: May 2008

Keywords provided by Dartmouth-Hitchcock Medical Center:
Systemic sepsis

Additional relevant MeSH terms:
Systemic Inflammatory Response Syndrome
Pathologic Processes
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Cortisol succinate
Anti-Inflammatory Agents