Corticosteroid Therapy in Refractory Shock Following Cardiac Arrest

This study is currently recruiting participants.

Verified July 2011 by Beth Israel Deaconess Medical Center

Sponsor:

Collaborator:

American Heart Association

Information provided by:

Beth Israel Deaconess Medical Center

ClinicalTrials.gov Identifier:

NCT00676585

First received: May 9, 2008

Last updated: July 19, 2011

Last verified: July 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

May 9, 2008

Last Updated Date

July 19, 2011

Start Date ^ICMJE

October 2007

Estimated Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Time to Shock Reversal [ Time Frame: 7 Days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00676585 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Mortality [ Time Frame: In Hospital ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Corticosteroid Therapy in Refractory Shock Following Cardiac Arrest

Official Title ^ICMJE

Corticosteroids Therapy in Refractory Shock Following Cardiac Arrest

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Cardiac Arrest

Intervention ^ICMJE

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

Study Arm (s)

Placebo Comparator: 2
Normal Saline

Intervention: Drug: Normal Saline
Experimental: 1
Hydrocortisone 100mg every 8 hours.

Intervention: Drug: Hydrocortisone

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2011

Estimated Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Michael W Donnino, MD

617-754-2295

mdonnino@bidmc.harvard.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00676585

Other Study ID Numbers ^ICMJE

2007P-000227

Has Data Monitoring Committee

Yes

Responsible Party

Michael Donnino, MD, Beth Isreal Deaconess Medical Center

Study Sponsor ^ICMJE

Beth Israel Deaconess Medical Center

Collaborators ^ICMJE

American Heart Association

Investigators ^ICMJE

Principal Investigator:

Michael W Donnino, MD

Beth Israel Deaconess Medical Center

Information Provided By

Beth Israel Deaconess Medical Center

Verification Date

July 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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