Corticosteroid Therapy in Refractory Shock Following Cardiac Arrest
Corticosteroids Therapy in Refractory Shock Following Cardiac Arrest
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Oct 2007
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 9, 2008
CompletedFirst Posted
Study publicly available on registry
May 13, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedResults Posted
Study results publicly available
May 17, 2017
CompletedMay 17, 2017
May 1, 2017
6.5 years
May 9, 2008
March 28, 2017
May 15, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to Shock Reversal
The primary outcome was time to shock reversal defined as at least 24 hours off all vasopressor medications.
7 Days
Secondary Outcomes (2)
Mortality
Length of hospital stay, an average of 9 days with a maximum of 36 days
Sub-group Analysis of Patients With Adrenal Insufficiency
At time of enrollment
Study Arms (2)
2
PLACEBO COMPARATORNormal Saline
1
EXPERIMENTALHydrocortisone 100mg every 8 hours.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beth Israel Deaconess Medical Centerlead
- American Heart Associationcollaborator
Study Sites (1)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Related Publications (1)
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.
PMID: 27038920DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Michael Donnino
- Organization
- Beth Israel Deaconess Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Michael W Donnino, MD
Beth Israel Deaconess Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Michael Donnino, MD
Study Record Dates
First Submitted
May 9, 2008
First Posted
May 13, 2008
Study Start
October 1, 2007
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
May 17, 2017
Results First Posted
May 17, 2017
Record last verified: 2017-05