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NCT04845607 Clinical Trial

Prophylactic Amiodarone for Shockable Cardiac Arrest

Cardiac Arrest Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04845607
Other study ID # PASCA trial
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date April 1, 2021
Est. completion date February 28, 2023

Study information
Verified date June 2021
Source Asan Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 302
Est. completion date February 28, 2023
Est. primary completion date February 28, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Amiodarone Injection
Amiodarone continuous infusion during 24 hours from return of spontaneous circulation.

Locations
Country Name City State
Korea, Republic of Asan Medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Won Young Kim

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Other 3 month survivor mortality 3 months after the time of hospital discharge
Other 3 months neurological outcome cerebral performance scales 3, 4 and 5 3 months after the time of hospital discharge
Primary Number of patients with re-arrest by shockable rhythm No recurrence of ventricular fibrillation or pulseless ventricular tachycardia 5 days from return of spontaneous circulation
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