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Impact of Hydrocortisone Administration on White Blood Cell Gene Expression in Patients With Severe Sepsis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00185783
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : April 11, 2011
University of Toronto
University of Colorado, Denver
Information provided by:
Stanford University

Brief Summary:
The purpose of this pilot study is to (1) examine the changes in gene expression in patients who suffer from severe sepsis and whose shock (inadequate oxygen delivery to vital organs) state does not respond to fluid and vasopressor administration, (2) to show that our sampling method of isolating RNA provides reliable and consistent data, (3) provide a basis for future gene expression studies in critically ill patients

Condition or disease Intervention/treatment
Sepsis Relative Adrenal Insufficiency Drug: Hydrocortisone Administration (Standard of Care Therapy)

Detailed Description:

Severe sepsis is characterized by inadequate perfusion of vital organs due to infection. More than 750,000 cases of severe sepsis occur each year in the United States. Mortality among patients with severe sepsis ranges from 7% to 50%. Initiation of antibiotic therapy within the first hour of diagnosis as well as fluid resuscitation and hemodynamic stabilization are primary goals of therapy.

Steroid administration has been shown to improve outcome in the subset of severe sepsis patients suffering from relative adrenal insufficiency. Although initial studies using high dose short course steroid therapy did not demonstrate efficacy, more recent studies of low dose longer duration hydrocortisone administration demonstrated a significant reduction in mortality at 28 days. The mechanism by which steroid administration affords protection is unclear. We hypothesize that steroid administration changes white blood cell gene and protein expression in severe sepsis patients from an immuno-inflammatory profile to a pattern consistent with healing.

Our first specific aim is to obtain plasma and total cellular RNA from leukocytes in the blood of ten patients admitted to Stanford Medical Center with the diagnosis of severe sepsis and adrenal insufficiency. Significant and distinct variations in whole blood leukocyte gene expression patterns occur depending upon the method of RNA isolation. We will attempt to demonstrate that our sampling method provides reliable and consistent data.

Our second specific aim is to begin an analysis of gene expression patterns in white blood cells before and after steroid administration in patients suffering from severe sepsis with relative adrenal insufficiency. We will use a protocol for assessment of gene expression that was developed by members of our research team.

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Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study of White Blood Cell Gene Expression in Critically Ill Patients With Severe Sepsis and Relative Adrenal Insufficiency After Hydrocortisone Administration
Study Start Date : March 2005
Actual Primary Completion Date : November 2006
Actual Study Completion Date : November 2006

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted to the Stanford Hospital ICU with Sepsis.

Inclusion Criteria:

  • Admission Diagnosis of Sepsis
  • Evidence of Relative Adrenal Insufficiency
  • Hypotension (Mean Arterial Pressure less than 60 mm Hg) Refractory to a. Fluid Resuscitation b. Dopamine infusion (greater than 5 micrograms/kg/min) c. Phenylephrine infusion (greater than 1 microgram/kg/min)

Exclusion Criteria:

  • Use of Immunosuppressant Medications
  • Immune Compromised Due to Disease (e.g., HIV infection)
  • Transfusion of Blood Products within the past 7 Days
  • Use of Cytokine Therapy (i.e., G-CSF)
  • History of Bone Marrow Transplantation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00185783

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United States, California
Stanford University Medical Center
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
University of Toronto
University of Colorado, Denver
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Principal Investigator: Andrew J Patterson, M.D., Ph.D. Stanford University, Dept. of Anesthesia, Division of Critical Care Medicine
Principal Investigator: Ann Weinacker, M.D., Stanford University, Dept. of Medicine, Div. of Pulmonary and Critical Care Medicine

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Responsible Party: Andrew J. Patterson, M.D., Ph.D., Stanford University Identifier: NCT00185783    
Other Study ID Numbers: 95230
Stanford IRB Number 4593
Other Grant ( Other Grant/Funding Number: Stanford University Department of Anesthesia )
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: April 11, 2011
Last Verified: April 2011
Keywords provided by Stanford University:
Adrenal Insufficiency
Gene Expression
Critically Ill
Additional relevant MeSH terms:
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Adrenal Insufficiency
Systemic Inflammatory Response Syndrome
Pathologic Processes
Adrenal Gland Diseases
Endocrine System Diseases
Anti-Inflammatory Agents