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NCT Number: NCT06680869

Early Amiodarone in Shockable Cardiac Arrest

The primary objective of this pilot, pragmatic stepped-wedge cluster randomized trial is to evaluate if a modified cardiac arrest treatment algorithm calling for the administration of the initial amiodarone dose one 2-minute cycle earlier than current guidelines (during the same cycle as the initial dose of epinephrine) improves the time to amiodarone delivery in those with out-of-hospital cardiac arrest due to refractory ventricular fibrillation or ventricular tachycardia compared to usual care.

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Key information

Conditions

Cardiac Arrest Cardiovascular Diseases Heart Arrest Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Oregon Health & Sciences University

Portland, Oregon, 97035, United States

Location status: Recruiting

Location contact

Joshua Lupton, MD, MPH

CONTACT

[email protected]

503-418-6706

Joshua Lupton, MD, MPH

PRINCIPAL_INVESTIGATOR

About this study

The primary objective of this pilot, pragmatic stepped-wedge cluster randomized trial is to evaluate if a modified cardiac arrest treatment algorithm calling for the administration of the initial amiodarone dose one 2-minute cycle earlier than current guidelines (during the same cycle as the initial dose of epinephrine) improves the time to amiodarone delivery in those with out-of-hospital cardiac arrest due to refractory ventricular fibrillation or ventricular tachycardia compared to usual care.

The null hypothesis is that there is no difference in time to amiodarone delivery, relative to emergency medical services (EMS) arrival on-scene or time of arrest if witnessed by EMS, in the modified protocol calling for earlier amiodarone administration compared to usual care.

Evaluated secondary outcomes will include the proportion of patients receiving amiodarone before their third defibrillation, pulses present at emergency department arrival, survival to hospital discharge, neurologically intact survival at hospital discharge, timing to other critical EMS interventions, and clinical adverse events.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Emergency medical services (EMS)-treated non-traumatic out-of-hospital cardiac arrest
  • Initial rhythm on EMS rhythm assessment of ventricular fibrillation or ventricular tachycardia
  • Recurrence or persistence of ventricular fibrillation or ventricular tachycardia after one defibrillation attempt

Exclusion criteria

  • Known allergy to amiodarone
  • EMS-assessed contraindication to amiodarone
  • Pre-existing "do-not-attempt-resuscitation" orders
  • Inter-facility transportations
  • Initial care by a non-participating EMS agency able to perform advanced life support interventions
  • Pediatric patient as determined by EMS
  • Prisoners
  • Pregnant patients

Treatment and study plan

Amiodarone Hydrochloride Injection

Drug

The use of a modified treatment protocol by emergency medical services where the initial dose of amiodarone is given after the second defibrillator shock, during the same two-minute cycle as the initial dose of epinephrine, for out-of-hospital cardiac arrest due to a shockable rhythm (ventricular fibrillation or ventricular tachycardia) that is persistent or recurs after at least one defibrillation attempt.

If an EMS agency is assigned to this arm, no downstream care after the initial dose of amiodarone is dictated by the study.

Other names: Early-Amiodarone Protocol

Usual Care Protocol

Other

The use of a usual care treatment protocol by emergency medical services where the initial dose of amiodarone is given after the third defibrillator shock, one two-minute cycle after the initial dose of epinephrine, for out-of-hospital cardiac arrest due to a shockable rhythm (ventricular fibrillation or ventricular tachycardia) that is persistent or recurs after at least one defibrillation attempt.

If an EMS agency is assigned to this arm, no downstream care after the initial dose of amiodarone is dictated by the study.

Primary outcomes

  1. Time from emergency medical services (EMS) arrival on-scene (or time of arrest if witnessed by EMS) to the administration of the initial dose of amiodarone in minutes

    Time frame: up to 1 day

Secondary outcomes

  1. The number and proportion of patients receiving the initial dose of amiodarone from emergency medical services before the third shock from a defibrillator

    Time frame: up to 1 day

  2. The number and proportion of patients with pulses present and documented by emergency medical services at the time of patient care transfer to hospital staff at emergency department arrival

    Time frame: up to 1 day

  3. The number and proportion of patients surviving to be admitted to inpatient services after arrival to the emergency department

    Time frame: up to 1 day

  4. The number and proportion of patients surviving to be discharged from the hospital (or 30 days, whichever is sooner) after their admission for cardiac arrest

    Time frame: up to 30 days

  5. The number and proportion of patients surviving to be discharged from the hospital (or 30 days, whichever is sooner) after their admission for cardiac arrest with a Cerebral Performance Category score of 1 or 2

    Time frame: up to 30 days

    The Cerebral Performance Category (CPC) score scale is 1-5:

    CPC 1: Good cerebral performance: conscious, alert, able to work, might have mild neurologic or psychologic deficit.

    CPC 2: Moderate cerebral disability: conscious, sufficient cerebral function for independent activities of daily life. Able to work in sheltered environment.

    CPC 3: Severe cerebral disability: conscious, dependent on others for daily support because of impaired brain function. Ranges from ambulatory state to severe dementia or paralysis.

    CPC 4: Coma or vegetative state: any degree of coma without the presence of all brain death criteria. Unawareness, even if appears awake (vegetative state) without interaction with environment; may have spontaneous eye opening and sleep/awake cycles. Cerebral unresponsiveness.

    CPC 5: Brain death: apnea, areflexia, EEG silence, etc.

  6. Time from emergency medical services (EMS) arrival on-scene (or time of arrest if witnessed by EMS) to the delivery of other critical interventions in minutes

    Time frame: up to 1 day

    Critical interventions include: the second-fourth defibrillator shocks, the first use of double sequential external defibrillation, the administration of the first two epinephrine doses, and the time to advanced airway placement by EMS.

  7. Number and proportion of participants with adverse events

    Time frame: up to 1 day

    e.g.: malignant cardiac arrhythmia, allergic reaction, recurrent cardiac arrest

Study contacts

Contact information is provided by the study sponsor or research team.

Joshua Lupton, MD, MPH

CONTACT

[email protected]

(503) 418-6706

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Early Amiodarone in Shockable Cardiac Arrest (Early-Amio) Study

Acronym: Early-Amio

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Nov 8, 2024
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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