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Corticosteroid Therapy in Refractory Shock Following Cardiac Arrest

Primary Purpose

Cardiac Arrest

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Normal Saline
Hydrocortisone
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest focused on measuring Cardiac Arrest, Shock, Steroids

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

2

1

Arm Description

Normal Saline

Hydrocortisone 100mg every 8 hours.

Outcomes

Primary Outcome Measures

Time to Shock Reversal
The primary outcome was time to shock reversal defined as at least 24 hours off all vasopressor medications.

Secondary Outcome Measures

Mortality
Sub-group Analysis of Patients With Adrenal Insufficiency
Sub-analysis of patients with adrenal insufficiency: absolute insufficiency as defined by a baseline cortisol level < 15 ug/dL

Full Information

First Posted
May 9, 2008
Last Updated
May 15, 2017
Sponsor
Beth Israel Deaconess Medical Center
Collaborators
American Heart Association
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1. Study Identification

Unique Protocol Identification Number
NCT00676585
Brief Title
Corticosteroid Therapy in Refractory Shock Following Cardiac Arrest
Official Title
Corticosteroids Therapy in Refractory Shock Following Cardiac Arrest
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
Collaborators
American Heart Association

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest
Keywords
Cardiac Arrest, Shock, Steroids

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Normal Saline
Arm Title
1
Arm Type
Experimental
Arm Description
Hydrocortisone 100mg every 8 hours.
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Intervention Description
Normal Saline
Intervention Type
Drug
Intervention Name(s)
Hydrocortisone
Intervention Description
Hydrocortisone 100mg
Primary Outcome Measure Information:
Title
Time to Shock Reversal
Description
The primary outcome was time to shock reversal defined as at least 24 hours off all vasopressor medications.
Time Frame
7 Days
Secondary Outcome Measure Information:
Title
Mortality
Time Frame
Length of hospital stay, an average of 9 days with a maximum of 36 days
Title
Sub-group Analysis of Patients With Adrenal Insufficiency
Description
Sub-analysis of patients with adrenal insufficiency: absolute insufficiency as defined by a baseline cortisol level < 15 ug/dL
Time Frame
At time of enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael W Donnino, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27038920
Citation
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.
Results Reference
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Corticosteroid Therapy in Refractory Shock Following Cardiac Arrest

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