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NCT Number: NCT00396344

Cortisol Control of Human Inflammatory Responses to Endotoxin

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.

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome Toxemia

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Çontrol

Other

Intravenous saline

Hydrocortisone

Drug

Intravenous stress dose of hydrocortisone

Primary outcomes

  1. Plasma cytokine responses to in vivo endotoxin administration

    Time frame: 4 Days

Secondary outcomes

  1. Plasma acute phase protein response

    Time frame: 4 Days

  2. Clinical response

    Time frame: 8 Hours

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

The Effect of Glucocorticoid Pre-Treatment on the Systemic Cytokine Response to Endotoxin in Human Volunteers

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Nov 6, 2006
Registry last updated
May 9, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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