Corticosteroids Therapy in Refractory Shock Following Cardiac Arrest

Beth Israel Deaconess Medical Center1 site in 1 country50 target enrollmentOctober 2007

ConditionsCardiac Arrest

InterventionsNormal Saline Hydrocortisone

DrugsNormal Saline Hydrocortisone

Overview

Phase: Phase 1
Intervention: Normal Saline
Conditions: Cardiac Arrest
Sponsor: Beth Israel Deaconess Medical Center
Enrollment: 50
Locations: 1
Primary Endpoint: Time to Shock Reversal
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2007

End Date

April 2014

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Beth Israel Deaconess Medical Center

Responsible Party

Principal Investigator

Michael Donnino

Michael Donnino, MD

Beth Israel Deaconess Medical Center

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

•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

Arms & Interventions

2

Normal Saline

Intervention: Normal Saline

1

Hydrocortisone 100mg every 8 hours.

Intervention: Hydrocortisone

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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)