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Corticosteroid Therapy in Refractory Shock Following Cardiac Arrest

This study is currently recruiting participants.
Verified July 2011 by Beth Israel Deaconess Medical Center
Sponsor:
Collaborator:
American Heart Association
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00676585
First received: May 9, 2008
Last updated: July 19, 2011
Last verified: July 2011
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Corticosteroids Therapy in Refractory Shock Following Cardiac Arrest

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Time to Shock Reversal [ Time Frame: 7 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mortality [ Time Frame: In Hospital ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: October 2007
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00676585

Contacts
Contact: Michael W Donnino, MD 617-754-2295 mdonnino@bidmc.harvard.edu

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Michael W Donnino, MD     617-754-2295     mdonnino@bidmc.harvard.edu    
Principal Investigator: Michael W Donnino, MD            
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
American Heart Association
Investigators
Principal Investigator: Michael W Donnino, MD Beth Israel Deaconess Medical Center
  More Information

No publications provided

Responsible Party: Michael Donnino, MD, Beth Isreal Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00676585     History of Changes
Other Study ID Numbers: 2007P-000227
Study First Received: May 9, 2008
Last Updated: July 19, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Heart Arrest
Shock
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cortisol succinate
Hydrocortisone acetate
 Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents

ClinicalTrials.gov processed this record on May 23, 2013