Cortisol Control of Human Inflammatory Responses to Endotoxin

NCT ID: NCT00396344

Last Updated: 2008-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2007-11-30

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.

Conditions

Sepsis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: QUADRUPLE

Study Groups

1

Saline control

Group Type: PLACEBO_COMPARATOR

Çontrol

Intervention Type: OTHER

Intravenous saline

2

Group Type: EXPERIMENTAL

Hydrocortisone

Intervention Type: DRUG

Intravenous stress dose of hydrocortisone

3

Group Type: EXPERIMENTAL

Hydrocortisone

Intervention Type: DRUG

Intravenous pharmacologic hydrocortisone

Interventions

Çontrol

Intravenous saline

Intervention Type: OTHER

Hydrocortisone

Intravenous stress dose of hydrocortisone

Intervention Type: DRUG

Hydrocortisone

Intravenous pharmacologic hydrocortisone

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Principal Investigators

Mark P Yeager, MD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Locations

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Countries

United States

References

Yeager MP, Rassias AJ, Pioli PA, Beach ML, Wardwell K, Collins JE, Lee HK, Guyre PM. Pretreatment with stress cortisol enhances the human systemic inflammatory response to bacterial endotoxin. Crit Care Med. 2009 Oct;37(10):2727-32. doi: 10.1097/ccm.0b013e3181a592b3.

Reference Type: DERIVED

PMID: 19885996 (View on PubMed)

Other Identifiers

NIH#AIO51547

Identifier Type: -

Identifier Source: secondary_id

CPHS#20361

Identifier Type: -

Identifier Source: org_study_id