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Prophylactic Amiodarone for Shockable Cardiac Arrest

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04845607
Enrollment
302
Registered
2021-04-15
Start date
2021-04-01
Completion date
2023-02-28
Last updated
2021-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrest, Ventricular Arrythmia

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.

Interventions

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

Sponsors

Won Young Kim
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of patients with re-arrest by shockable rhythm5 days from return of spontaneous circulationNo recurrence of ventricular fibrillation or pulseless ventricular tachycardia

Other

MeasureTime frameDescription
3 month survivor3 months after the time of hospital dischargemortality
3 months neurological outcome3 months after the time of hospital dischargecerebral performance scales 3, 4 and 5

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026