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Early Amiodarone in Shockable Cardiac Arrest

ConditionCardiac Arrest
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorOregon Health and Science University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Known allergy to amiodarone

EMS-assessed contraindication to amiodarone

Pre-existing "do-not-attempt-resuscitation" orders

Inter-facility transportations

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Usual Care Protocol

    Other intervention

    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.

Treatment groups

585 Participants
are divided into 2 treatment groups
Group A: Early Amiodarone ProtocolExperimental treatment 1 intervention
Group B: Usual Care ProtocolActive comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Oregon Health and Science University

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov
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