Cortisol Control of Human Inflammatory Responses to Endotoxin
Information source: Dartmouth-Hitchcock Medical Center
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sepsis
Intervention: Çontrol (Other); Hydrocortisone (Drug); Hydrocortisone (Drug)
Sponsored by: Dartmouth-Hitchcock Medical Center
Official(s) and/or principal investigator(s):
Mark P Yeager, MD, Principal Investigator, Affiliation: Dartmouth-Hitchcock Medical Center
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.
Official title: The Effect of Glucocorticoid Pre-Treatment on the Systemic Cytokine Response to Endotoxin in Human Volunteers
Study design: Other, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment
Primary outcome: Plasma cytokine responses to in vivo endotoxin administration
Plasma acute phase protein response
Minimum age: 18 Years.
Maximum age: 55 Years.
- 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.
- 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)
- History of known risk factors for HIV infection (recent multiple partners, sexually
transmitted disease and unprotected sex; intravenous drug use; blood transfusion
Locations and Contacts
Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire 03756, United States
Starting date: October 2006
Ending date: November 2007
Last updated: May 6, 2008