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Completed

NCT Number: NCT00676585

Corticosteroid 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.

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Key information

Conditions

Cardiac Arrest Cardiovascular Diseases Heart Arrest Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Shock

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

normal saline

Drug

Normal Saline

Hydrocortisone

Drug

Hydrocortisone 100mg

Primary outcomes

  1. 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.

Secondary outcomes

  1. Mortality

    Time frame: Length of hospital stay, an average of 9 days with a maximum of 36 days

  2. 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

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • American Heart Association

Registry information

Official study title

Corticosteroids Therapy in Refractory Shock Following Cardiac Arrest

Important dates

Study start
2007
Primary completion
2014
Study completion
2014
First posted
May 13, 2008
Registry last updated
May 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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