Phase 2 N=50 Randomized Triple-blind Treatment

Corticosteroid Therapy in Refractory Shock Following Cardiac Arrest

Cardiac Arrest

Bottom Line

View on ClinicalTrials.gov: NCT00676585 ↗

Enrolled (actual)

Serious AEs

68.0%

Results posted

May 2017

Primary outcome: Primary: Time to Shock Reversal — 55; 49 hours

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Normal Saline (Drug); Hydrocortisone (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Beth Israel Deaconess Medical Center
Primary completion: Apr 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Time to Shock Reversal	55; 49	—
SECONDARY Mortality	16; 18	—
SECONDARY Sub-group Analysis of Patients With Adrenal Insufficiency	1; 6; 0; 2; 0; 3	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00676585). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.