NCT00396344

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for not_applicable sepsis

Timeline
Completed

Started Oct 2006

Shorter than P25 for not_applicable sepsis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 3, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 6, 2006

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

May 9, 2008

Status Verified

May 1, 2008

Enrollment Period

1.1 years

First QC Date

November 3, 2006

Last Update Submit

May 6, 2008

Conditions

Sepsis

Keywords

Systemic sepsis

Outcome Measures

Primary Outcomes (1)

  • Plasma cytokine responses to in vivo endotoxin administration

    4 Days

Secondary Outcomes (2)

  • Plasma acute phase protein response

    4 Days

  • Clinical response

    8 Hours

Study Arms (3)

1

PLACEBO COMPARATOR

Saline control

Other: Çontrol

2

EXPERIMENTAL
Drug: Hydrocortisone

3

EXPERIMENTAL
Drug: Hydrocortisone

Interventions

ÇontrolOTHER

Intravenous saline

1
HydrocortisoneDRUG

Intravenous stress dose of hydrocortisone

2

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \< 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Related Publications (1)

  • 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.

    PMID: 19885996DERIVED

MeSH Terms

Conditions

SepsisToxemia

Interventions

Hydrocortisone

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds11-HydroxycorticosteroidsHydroxycorticosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists17-Hydroxycorticosteroids

Study Officials

  • Mark P Yeager, MD

    Dartmouth-Hitchcock Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 3, 2006

First Posted

November 6, 2006

Study Start

October 1, 2006

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

May 9, 2008

Record last verified: 2008-05

Locations

US(1)