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
• Status: Recruiting
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest
• Ventricular Arrythmia

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