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Sponsors and Collaborators: |
Dartmouth-Hitchcock Medical Center National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | Dartmouth-Hitchcock Medical Center |
ClinicalTrials.gov Identifier: | NCT00396344 |
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 |
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Sepsis |
Other: Çontrol Drug: Hydrocortisone |
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 |
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 |
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1: Placebo Comparator
Saline control
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Other: Çontrol
Intravenous saline
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2: Experimental |
Drug: Hydrocortisone
Intravenous stress dose of hydrocortisone
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3: Experimental |
Drug: Hydrocortisone
Intravenous pharmacologic hydrocortisone
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Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, New Hampshire | |
Dartmouth Hitchcock Medical Center | |
Lebanon, New Hampshire, United States, 03756 |
Principal Investigator: | Mark P Yeager, MD | Dartmouth-Hitchcock Medical Center |
Study ID Numbers: | CPHS#20361, NIH#AIO51547 |
Study First Received: | November 3, 2006 |
Last Updated: | May 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00396344 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Systemic sepsis |
Anti-Inflammatory Agents Systemic Inflammatory Response Syndrome Sepsis Hydrocortisone |
Cortisol succinate Hydrocortisone acetate Glucocorticoids Inflammation |
Anti-Inflammatory Agents Systemic Inflammatory Response Syndrome Sepsis Hydrocortisone Pathologic Processes Cortisol succinate |
Therapeutic Uses Hydrocortisone acetate Infection Pharmacologic Actions Inflammation |