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Clinical Trials/NCT04845607
NCT04845607
Unknown
Phase 3

Prophylactic Amiodarone for Shockable Cardiac Arrest During Targeted Post Cardiac Arrest Care: Multi-center, Open Labelled Randomized Controlled Trial

Won Young Kim1 site in 1 country302 target enrollmentApril 1, 2021

Overview

Phase
Phase 3
Intervention
Amiodarone Injection
Conditions
Cardiac Arrest
Sponsor
Won Young Kim
Enrollment
302
Locations
1
Primary Endpoint
Number of patients with re-arrest by shockable rhythm
Last Updated
4 years ago

Overview

Brief Summary

The aim of this study is to determine whether the prophylactic amiodarone can prevent re-arrest with ventricular shockable rhythm in patients who treated with targeted temperature management after return of spontaneous circulation from cardiac arrest which had been shockable rhythm during CPR.

Detailed Description

Patients with cardiac arrest are in high risk of re-arrest during post cardiac arrest care due to vulnerable heart state electrically and hemodynamically. Especially if patients who had experienced shockable rhythms such as ventricular fibrillation or pulseless ventricular tachycardia during CPR, then they are at high risk of developing shockable re-arrest. However until now there has not been any evidence of prophylactic anti arrhythmic drug effect during post cardiac arrest care. Amiodarone is class III anti arrhythmic drug which has been used for conversion of ventricular arrhythmia during CPR. In this study we want to determine whether the prophylactic amiodarone can prevent re-arrest with ventricular shockable rhythm or not.

Registry
clinicaltrials.gov
Start Date
April 1, 2021
End Date
February 28, 2023
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Won Young Kim
Responsible Party
Sponsor Investigator
Principal Investigator

Won Young Kim

Professor

Asan Medical Center

Eligibility Criteria

Inclusion Criteria

  • Non traumatic cardiac arrest patients who had VF or pVT during CPR in ER

Exclusion Criteria

  • age \< 18 yr
  • pregnancy
  • non cardiac caused arrest such as hanging
  • previous amiodarone continuous infusion before radomization
  • sustained ventricular arrhythmia recurrence after ROSC
  • extracorporeal membrane oxygenation
  • contra indication for amiodarone
  • disagree with this research

Arms & Interventions

Prophylactic amiodarone

Intervention: Amiodarone Injection

Outcomes

Primary Outcomes

Number of patients with re-arrest by shockable rhythm

Time Frame: 5 days from return of spontaneous circulation

No recurrence of ventricular fibrillation or pulseless ventricular tachycardia

Study Sites (1)

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