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Physiologic Effects of Steroids in Cardiac Arrest

NCT02790788 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-11-23

Study results available
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Summary

Early stress-dose steroids are of uncertain efficacy in cardiac arrest. The current authors plan to conduct a prospective, randomized, placebo controlled evaluation of stress-dose steroids efficacy with repect to early postresuscitation hemodynamics, heart function, brain perfusion, and inflammatory response in vasopressor-requiring cardiac arrest. Patients will also be followed for organ dysfunction, potential, steroid-associated complications, and functional outcome at hospital discharge.

Conditions

  • Inhospital Cardiac Arrest

Interventions

DRUG

Methylprednisolone; hydrocortisone

Methylprednisolone 40 mg during resuscitation and stress-dose hydrocortisone for postresuscitation shock

DRUG

Saline Placebo

Saline placebo during resuscitation and during the postresuscitation phase.

Sponsors & Collaborators

  • University of Thessaly

    collaborator OTHER

  • University of Athens

    lead OTHER

Principal Investigators

  • Spyros D. Mentzelopoulos, MD, PhD · University of Athens

  • Spyros G. Zakynthinos, MD, PhD · University of Athens

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-04
Primary Completion
2018-05-22
Completion
2018-08-11

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02790788 on ClinicalTrials.gov