Prophylactic Amiodarone for Shockable Cardiac Arrest

Won Young Kim

Status and phase: Unknown; Phase 3

Conditions: Ventricular Arrythmia; Cardiac Arrest

Treatments: Drug: Amiodarone Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04845607

PASCA trial

Details and patient eligibility

About

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.

Full 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.

Enrollment: 302 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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302 participants in 2 patient groups

Prophylactic amiodarone

Experimental group

Treatment:

Drug: Amiodarone Injection

Conventional management

No Intervention group