Corticosteroid Therapy in Refractory Shock Following Cardiac Arrest

NCT ID: NCT00676585

Last Updated: 2017-05-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2014-04-30

Brief Summary

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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

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Conditions

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Cardiac Arrest

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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2

Normal Saline

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type DRUG

Normal Saline

1

Hydrocortisone 100mg every 8 hours.

Group Type EXPERIMENTAL

Hydrocortisone

Intervention Type DRUG

Hydrocortisone 100mg

Interventions

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Normal Saline

Normal Saline

Intervention Type DRUG

Hydrocortisone

Hydrocortisone 100mg

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Heart Association

OTHER

Sponsor Role collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Michael Donnino

Michael Donnino, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael W Donnino, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

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Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Donnino MW, Andersen LW, Berg KM, Chase M, Sherwin R, Smithline H, Carney E, Ngo L, Patel PV, Liu X, Cutlip D, Zimetbaum P, Cocchi MN; Collaborating Authors from the Beth Israel Deaconess Medical Center's Center for Resuscitation Science Research Group. Corticosteroid therapy in refractory shock following cardiac arrest: a randomized, double-blind, placebo-controlled, trial. Crit Care. 2016 Apr 3;20:82. doi: 10.1186/s13054-016-1257-x.

Reference Type DERIVED
PMID: 27038920 (View on PubMed)

Other Identifiers

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2007P000227

Identifier Type: -

Identifier Source: org_study_id

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