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Prophylactic Amiodarone for Shockable Cardiac Arrest

Primary Purpose

Cardiac Arrest, Ventricular Arrythmia

Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Amiodarone Injection
Sponsored by
Won Young Kim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiac Arrest

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Asan Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Prophylactic amiodarone

Conventional management

Arm Description

Outcomes

Primary Outcome Measures

Number of patients with re-arrest by shockable rhythm
No recurrence of ventricular fibrillation or pulseless ventricular tachycardia

Secondary Outcome Measures

Full Information

First Posted
April 11, 2021
Last Updated
June 16, 2021
Sponsor
Won Young Kim
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1. Study Identification

Unique Protocol Identification Number
NCT04845607
Brief Title
Prophylactic Amiodarone for Shockable Cardiac Arrest
Official Title
Prophylactic Amiodarone for Shockable Cardiac Arrest During Targeted Post Cardiac Arrest Care: Multi-center, Open Labelled Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
February 28, 2023 (Anticipated)
Study Completion Date
February 28, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Won Young Kim

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest, Ventricular Arrythmia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
302 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prophylactic amiodarone
Arm Type
Experimental
Arm Title
Conventional management
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Amiodarone Injection
Intervention Description
Amiodarone continuous infusion during 24 hours from return of spontaneous circulation.
Primary Outcome Measure Information:
Title
Number of patients with re-arrest by shockable rhythm
Description
No recurrence of ventricular fibrillation or pulseless ventricular tachycardia
Time Frame
5 days from return of spontaneous circulation
Other Pre-specified Outcome Measures:
Title
3 month survivor
Description
mortality
Time Frame
3 months after the time of hospital discharge
Title
3 months neurological outcome
Description
cerebral performance scales 3, 4 and 5
Time Frame
3 months after the time of hospital discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Won Young Kim, MD,PhD
Phone
+82-2-3010-3350
Email
wonpia73@naver.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Prophylactic Amiodarone for Shockable Cardiac Arrest

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