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Cortisol Control of Human Inflammatory Responses to Endotoxin

This study has been completed.
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT00396344
First received: November 3, 2006
Last updated: May 6, 2008
Last verified: May 2008
History of Changes
  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

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

Resource links provided by NLM:

MedlinePlus related topics: Sepsis
U.S. FDA Resources

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
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

  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

No publications provided by Dartmouth-Hitchcock Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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

Keywords provided by Dartmouth-Hitchcock Medical Center:
Systemic sepsis

Additional relevant MeSH terms:
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Cortisol succinate
Hydrocortisone acetate
 Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents

ClinicalTrials.gov processed this record on June 18, 2013