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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.
Register: ClinicalTrials.gov
Last refreshed on: 17 October 2012
Main ID:  NCT00676585
Date of registration: 09/05/2008
Primary sponsor: Beth Israel Deaconess Medical Center
Public title: Corticosteroid Therapy in Refractory Shock Following Cardiac Arrest
Scientific title: Corticosteroids Therapy in Refractory Shock Following Cardiac Arrest
Date of first enrolment: October 2007
Target sample size: 50
Recruitment status: Recruiting
URL:  http://clinicaltrials.gov/show/NCT00676585
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment  
Countries of recruitment
United States
Contacts
Name:   Michael W Donnino, MD
Address: 
Telephone: 617-754-2295
Email: mdonnino@bidmc.harvard.edu
Affiliation: 
Name:   Michael W Donnino, MD
Address: 
Telephone: 617-754-2295
Email: mdonnino@bidmc.harvard.edu
Affiliation: 
Name:   Michael W Donnino, MD
Address: 
Telephone:
Email:
Affiliation:  Beth Israel Deaconess Medical Center
Key inclusion & exclusion criteria

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
Health Condition(s) or Problem(s) studied
Cardiac Arrest
Intervention(s)
Drug: Hydrocortisone
Drug: Normal Saline
Primary Outcome(s)
Time to Shock Reversal [Time Frame: 7 Days]
Secondary Outcome(s)
Mortality [Time Frame: In Hospital]
Secondary ID(s)
2007P-000227
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
American Heart Association
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