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Corticosteroid Therapy in Refractory Shock Following Cardiac Arrest

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00676585
Recruitment Status : Completed
First Posted : May 13, 2008
Results First Posted : May 17, 2017
Last Update Posted : May 17, 2017
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Michael Donnino, Beth Israel Deaconess Medical Center

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Cardiac Arrest Drug: Normal Saline Drug: Hydrocortisone Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Corticosteroids Therapy in Refractory Shock Following Cardiac Arrest
Study Start Date : October 2007
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: 2
Normal Saline
 Drug: Normal Saline
Normal Saline
Experimental: 1
Hydrocortisone 100mg every 8 hours.
 Drug: Hydrocortisone
Hydrocortisone 100mg


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. Mortality [ Time Frame: Length of hospital stay, an average of 9 days with a maximum of 36 days ]
  2. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00676585


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
American Heart Association
Investigators
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Principal Investigator: Michael W Donnino, MD Beth Israel Deaconess Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Michael Donnino, Michael Donnino, MD, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00676585    
Other Study ID Numbers: 2007P000227
First Posted: May 13, 2008    Key Record Dates
Results First Posted: May 17, 2017
Last Update Posted: May 17, 2017
Last Verified: May 2017
Keywords provided by Michael Donnino, Beth Israel Deaconess Medical Center:
Cardiac Arrest, Shock, Steroids
Additional relevant MeSH terms:
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Heart Arrest
Heart Diseases
Cardiovascular Diseases
Hydrocortisone
Anti-Inflammatory Agents