Corticosteroid Therapy in Refractory Shock Following Cardiac Arrest

Cardiac Arrest Clinical Trial

Official title:

Corticosteroids Therapy in Refractory Shock Following Cardiac Arrest

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00676585
• Other study ID #: 2007P000227
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 9, 2008
• Last updated: May 15, 2017
• Start date: October 2007
• Est. completion date: April 2014

Study information

• Verified date: May 2017
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest

Intervention

Drug:
• Normal Saline
Normal Saline
• Hydrocortisone
Hydrocortisone 100mg

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mortality		Length of hospital stay, an average of 9 days with a maximum of 36 days
Secondary	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	At time of enrollment