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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00185783 |
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Date of registration:
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12/09/2005 |
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Primary sponsor: |
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Public title:
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Impact of Hydrocortisone Administration on White Blood Cell Gene Expression in Patients With Severe Sepsis
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Scientific title:
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Pilot Study of White Blood Cell Gene Expression in Critically Ill Patients With Severe Sepsis and Relative Adrenal Insufficiency After Hydrocortisone Administration |
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Date of first enrolment:
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March 2005 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00185783 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Countries of recruitment
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United States
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Contacts
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Name:
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Andrew J Patterson, M.D., Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Stanford University, Dept. of Anesthesia, Division of Critical Care Medicine |
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Name:
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Ann Weinacker, M.D., |
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Address:
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Telephone:
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Email:
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Affiliation:
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Stanford University, Dept. of Medicine, Div. of Pulmonary and Critical Care Medicine |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Relative Adrenal Insufficiency
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Sepsis
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Intervention(s)
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Drug: Hydrocortisone Administration (Standard of Care Therapy)
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Secondary ID(s)
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95230
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Other Grant
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Stanford IRB Number 4593
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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