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Corticosteroid Therapy in Refractory Shock Following Cardiac Arrest

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00676585
First Posted: May 13, 2008
Last Update Posted: May 17, 2017
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.
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Michael Donnino, Beth Israel Deaconess Medical Center
May 9, 2008
May 13, 2008
March 28, 2017
May 17, 2017
May 17, 2017
October 2007
April 2014   (Final data collection date for primary outcome measure)
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.
Time to Shock Reversal [ Time Frame: 7 Days ]
Complete list of historical versions of study NCT00676585 on ClinicalTrials.gov Archive Site
  • 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
Mortality [ Time Frame: In Hospital ]
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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Donnino MW, Andersen LW, Berg KM, Chase M, Sherwin R, Smithline H, Carney E, Ngo L, Patel PV, Liu X, Cutlip D, Zimetbaum P, Cocchi MN; Collaborating Authors from the Beth Israel Deaconess Medical Center’s Center for Resuscitation Science Research Group. Corticosteroid therapy in refractory shock following cardiac arrest: a randomized, double-blind, placebo-controlled, trial. Crit Care. 2016 Apr 3;20:82. doi: 10.1186/s13054-016-1257-x.

*   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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00676585
2007P000227
Yes
Not Provided
Not Provided
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
May 2017

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