Impact of Hydrocortisone Administration on White Blood Cell Gene Expression in Patients With Severe Sepsis
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|ClinicalTrials.gov Identifier: NCT00185783|
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : April 11, 2011
|Condition or disease||Intervention/treatment||Phase|
|Sepsis Relative Adrenal Insufficiency||Drug: Hydrocortisone Administration (Standard of Care Therapy)||Phase 1|
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.
|Study Type :||Observational|
|Actual Enrollment :||10 participants|
|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|
|Primary Completion Date :||November 2006|
|Study Completion Date :||November 2006|
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 ClinicalTrials.gov identifier (NCT number): NCT00185783
|United States, California|
|Stanford University Medical Center|
|Stanford, California, United States, 94305|
|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|