Corticosteroid Therapy in Refractory Shock Following Cardiac Arrest

This study has been completed.
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Michael Donnino, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00676585
First received: May 9, 2008
Last updated: September 16, 2014
Last verified: August 2014

May 9, 2008
September 16, 2014
October 2007
April 2014   (final data collection date for primary outcome measure)
Time to Shock Reversal [ Time Frame: 7 Days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00676585 on ClinicalTrials.gov Archive Site
  • Mortality [ Time Frame: In Hospital ] [ Designated as safety issue: No ]
  • Sub-group analysis [ Time Frame: at enrollment ] [ Designated as safety issue: No ]
    sub-analysis of patients with adrenal insufficiency (cortisol < 15) sub-analysis of patients with failure of cort stim test (>9)
Mortality [ Time Frame: In Hospital ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Corticosteroid Therapy in Refractory Shock Following Cardiac Arrest
Corticosteroids Therapy in Refractory Shock Following Cardiac Arrest

The major goal of this project is to determine whether the use of physiologic doses of corticosteroids will decrease time to shock reversal, alters the inflammatory cascade, and alters microcirculatory flow in post-cardiac arrest patients.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Cardiac Arrest
  • Drug: Normal Saline
    Normal Saline
  • Drug: Hydrocortisone
    Hydrocortisone 100mg
  • Placebo Comparator: 2
    Normal Saline
    Intervention: Drug: Normal Saline
  • Experimental: 1
    Hydrocortisone 100mg every 8 hours.
    Intervention: Drug: Hydrocortisone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
April 2014
April 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00676585
2007P-000227
Yes
Michael Donnino, Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
American Heart Association
Principal Investigator: Michael W Donnino, MD Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP