NCT04845607

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
302

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

April 11, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 15, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

June 21, 2021

Status Verified

June 1, 2021

Enrollment Period

1.9 years

First QC Date

April 11, 2021

Last Update Submit

June 16, 2021

Conditions

Cardiac ArrestVentricular Arrythmia

Outcome Measures

Primary Outcomes (1)

  • 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

Other Outcomes (2)

  • 3 month survivor

    3 months after the time of hospital discharge

  • 3 months neurological outcome

    3 months after the time of hospital discharge

Study Arms (2)

Prophylactic amiodarone

EXPERIMENTAL
Drug: Amiodarone Injection

Conventional management

NO INTERVENTION

Interventions

Amiodarone InjectionDRUG

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

Prophylactic amiodarone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non traumatic cardiac arrest patients who had VF or pVT during CPR in ER

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

MeSH Terms

Conditions

Heart Arrest

Interventions

Amiodarone

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

BenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 11, 2021

First Posted

April 15, 2021

Study Start

April 1, 2021

Primary Completion

February 28, 2023

Study Completion

February 28, 2023

Last Updated

June 21, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)