Corticosteroid Therapy in Refractory Shock Following Cardiac Arrest

May 15, 2017 updated by: Michael Donnino, Beth Israel Deaconess Medical Center

Corticosteroids Therapy in Refractory Shock Following Cardiac Arrest

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 2
Normal Saline
Drug: Normal Saline
Normal Saline
EXPERIMENTAL: 1
Hydrocortisone 100mg every 8 hours.
Drug: Hydrocortisone
Hydrocortisone 100mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Shock Reversal
Time Frame: 7 Days
The primary outcome was time to shock reversal defined as at least 24 hours off all vasopressor medications.
7 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: Length of hospital stay, an average of 9 days with a maximum of 36 days
Length of hospital stay, an average of 9 days with a maximum of 36 days
Sub-group Analysis of Patients With Adrenal Insufficiency
Time Frame: At time of enrollment
Sub-analysis of patients with adrenal insufficiency: absolute insufficiency as defined by a baseline cortisol level < 15 ug/dL
At time of enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beth Israel Deaconess Medical Center

Collaborators

American Heart Association

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (ACTUAL)

April 1, 2014

Study Completion (ACTUAL)

April 1, 2014

Study Registration Dates

First Submitted

May 9, 2008

First Submitted That Met QC Criteria

May 9, 2008

First Posted (ESTIMATE)

May 13, 2008

Study Record Updates

Last Update Posted (ACTUAL)

May 17, 2017

Last Update Submitted That Met QC Criteria

May 15, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007P000227

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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