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
  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:


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 ]
  • 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)


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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00676585

Locations
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
Principal Investigator: Michael W Donnino, MD Beth Israel Deaconess Medical Center
  More Information

No publications provided

Responsible Party: Michael Donnino, Michael Donnino, MD, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00676585     History of Changes
Other Study ID Numbers: 2007P-000227
Study First Received: May 9, 2008
Last Updated: September 16, 2014
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
Heart Diseases
Cardiovascular Diseases
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Cortisol succinate
Hydrocortisone
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents

ClinicalTrials.gov processed this record on October 02, 2014