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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
Results First Submitted: March 28, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Cardiac Arrest
Interventions: Drug: Normal Saline
Drug: Hydrocortisone

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Control Normal Saline
Intervention Hydrocortisone

Participant Flow:   Overall Study
    Control   Intervention
STARTED   25   25 
COMPLETED   25   25 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Control Normal Saline
Intervention Hydrocortisone
Total Total of all reporting groups

Baseline Measures
   Control   Intervention   Total 
Overall Participants Analyzed 
[Units: Participants]
 25   25   50 
Age 
[Units: Years]
Mean (Standard Deviation)
 71  (13)   66  (15)   69  (14) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      8  32.0%      9  36.0%      17  34.0% 
Male      17  68.0%      16  64.0%      33  66.0% 


  Outcome Measures
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1.  Primary:   Time to Shock Reversal   [ Time Frame: 7 Days ]

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

3.  Secondary:   Sub-group Analysis of Patients With Adrenal Insufficiency   [ Time Frame: At time of enrollment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Michael Donnino
Organization: Beth Israel Deaconess Medical Center
e-mail: mdonnino@bidmc.harvard.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Michael Donnino, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00676585     History of Changes
Other Study ID Numbers: 2007P000227
First Submitted: May 9, 2008
First Posted: May 13, 2008
Results First Submitted: March 28, 2017
Results First Posted: May 17, 2017
Last Update Posted: May 17, 2017