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Corticosteroid Therapy in Refractory Shock Following Cardiac Arrest

This study has been completed.
American Heart Association
Information provided by (Responsible Party):
Michael Donnino, Beth Israel Deaconess Medical Center Identifier:
First received: May 9, 2008
Last updated: May 15, 2017
Last verified: May 2017
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.

Condition Intervention Phase
Cardiac Arrest
Drug: Normal Saline
Drug: Hydrocortisone
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator
Primary Purpose: Treatment
Official Title: Corticosteroids Therapy in Refractory Shock Following Cardiac Arrest

Resource links provided by NLM:

Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Time to Shock Reversal [ Time Frame: 7 Days ]
    The primary outcome was time to shock reversal defined as at least 24 hours off all vasopressor medications.

Secondary Outcome Measures:
  • Mortality [ Time Frame: Length of hospital stay, an average of 9 days with a maximum of 36 days ]
  • Sub-group Analysis of Patients With Adrenal Insufficiency [ Time Frame: At time of enrollment ]
    Sub-analysis of patients with adrenal insufficiency: absolute insufficiency as defined by a baseline cortisol level < 15 ug/dL

Enrollment: 50
Study Start Date: October 2007
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 2
Normal Saline
Drug: Normal Saline
Normal Saline
Experimental: 1
Hydrocortisone 100mg every 8 hours.
Drug: Hydrocortisone
Hydrocortisone 100mg


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00676585

United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
American Heart Association
Principal Investigator: Michael W Donnino, MD Beth Israel Deaconess Medical Center
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Michael Donnino, Michael Donnino, MD, Beth Israel Deaconess Medical Center Identifier: NCT00676585     History of Changes
Other Study ID Numbers: 2007P000227
Study First Received: May 9, 2008
Results First Received: March 28, 2017
Last Updated: May 15, 2017

Keywords provided by Beth Israel Deaconess Medical Center:
Cardiac Arrest, Shock, Steroids

Additional relevant MeSH terms:
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Hydrocortisone 17-butyrate 21-propionate
Cortisol succinate
Hydrocortisone acetate
Anti-Inflammatory Agents processed this record on May 24, 2017