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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: |
NCT00676585 |
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Date of registration:
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09/05/2008 |
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Primary sponsor: |
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Public title:
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Corticosteroid Therapy in Refractory Shock Following Cardiac Arrest
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Scientific title:
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Corticosteroids Therapy in Refractory Shock Following Cardiac Arrest |
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Date of first enrolment:
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October 2007 |
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Target sample size:
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50 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00676585 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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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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Michael W Donnino, MD |
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Address:
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Telephone:
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617-754-2295 |
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Email:
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mdonnino@bidmc.harvard.edu |
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Affiliation:
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Name:
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Michael W Donnino, MD |
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Address:
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Telephone:
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617-754-2295 |
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Email:
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mdonnino@bidmc.harvard.edu |
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Affiliation:
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Name:
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Michael W Donnino, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Beth Israel Deaconess Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Greater than 18 years old
- Either pre-hospital cardiac arrest and ROSC or Inpatient Cardiac Arrest with resultant ROSC
- Vasopressor dependent for a minimum of 1 hour post-arrest
Exclusion Criteria:
- Pregnant
- Indication for Corticosteroids outside of current research proposal
- DNR or comfort care measures
- Presence of septic shock
- Chronic Use (>1week) of oral Corticosteroids in the last year
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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Cardiac Arrest
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Intervention(s)
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Drug: Hydrocortisone
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Drug: Normal Saline
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Primary Outcome(s)
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Time to Shock Reversal
[Time Frame: 7 Days]
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Secondary Outcome(s)
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Mortality
[Time Frame: In Hospital]
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Secondary ID(s)
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2007P-000227
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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