Corticosteroid Therapy in Refractory Shock Following Cardiac Arrest

This study is currently recruiting participants.

Verified by Beth Israel Deaconess Medical Center, May 2008

First Received: May 9, 2008 No Changes Posted

Sponsors and Collaborators:	Beth Israel Deaconess Medical Center American Heart Association
Information provided by:	Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:	NCT00676585

Purpose

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.

Condition	Intervention	Phase
Cardiac Arrest	Drug: Normal Saline Drug: Hydrocortisone	Phase I Phase II

Drug Information available for: Hydrocortisone acetate Hydrocortisone Proctofoam-HC Hydrocortisone hemisuccinate Hydrocortamate Hydrocortisone 21-sodium succinate Hydrocortisone cypionate Cortisol succinate Cortisol 21-phosphate Corticosteroids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Corticosteroids Therapy in Refractory Shock Following Cardiac Arrest

Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	50
Study Start Date:	October 2007
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Placebo Comparator Normal Saline	Drug: Normal Saline Normal Saline
1: Experimental Hydrocortisone 100mg every 8 hours.	Drug: Hydrocortisone Hydrocortisone 100mg

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00676585

Contacts

Contact: Michael W Donnino, MD

617-754-2295

mdonnino@bidmc.harvard.edu

Locations

United States, Massachusetts
Beth Israel Deaconess Medical Center	Recruiting
Boston, Massachusetts, United States, 02215
Contact: Michael W Donnino, MD 617-754-2295 mdonnino@bidmc.harvard.edu
Principal Investigator: Michael W Donnino, MD

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

American Heart Association

Investigators

Principal Investigator:

Michael W Donnino, MD

Beth Israel Deaconess Medical Center

More Information

No publications provided

Responsible Party:	Beth Isreal Deaconess Medical Center ( Michael Donnino, MD )
Study ID Numbers:	2007P-000227
Study First Received:	May 9, 2008
Last Updated:	May 9, 2008
ClinicalTrials.gov Identifier:	NCT00676585 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:

Cardiac Arrest, Shock, Steroids

Study placed in the following topic categories:

Anti-Inflammatory Agents
Hydrocortisone
Heart Diseases
Cortisol succinate

Shock
Heart Arrest
Hydrocortisone acetate

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Hydrocortisone
Heart Diseases
Cortisol succinate
Therapeutic Uses

Cardiovascular Diseases
Heart Arrest
Hydrocortisone acetate
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009