Prophylactic Amiodarone for Shockable Cardiac Arrest

NCT ID: NCT04845607

Last Updated: 2021-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

302 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2023-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiac Arrest Ventricular Arrythmia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Prophylactic amiodarone

Group Type EXPERIMENTAL

Amiodarone Injection

Intervention Type DRUG

Amiodarone continuous infusion during 24 hours from return of spontaneous circulation.

Conventional management

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Amiodarone Injection

Amiodarone continuous infusion during 24 hours from return of spontaneous circulation.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Won Young Kim

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Won Young Kim

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Asan Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Won Young Kim, MD,PhD

Role: primary

+82-2-3010-3350

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PASCA trial

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.