Epinephrine Dose: Optimal Versus Standard Evaluation Trial

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUnity Health Toronto

About this trial

The objective of this randomized controlled trial is to evaluate whether a low cumulative dose of epinephrine ("low dose") is non-inferior to a standard cumulative dose of epinephrine ("standard dose") with respect to survival to hospital discharge among adults undergoing resuscitation for OHCA due to ventricular fibrillation (VF) or pulseless ventricular tachycardia (pVT).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Out-of-hospital cardiac arrest treated by paramedics AND

Initial recorded cardiac rhythm of VF or pulseless VT, or, AED shock on first analysis administered or confirmed by paramedics or fire services, AND

Established intravenous vascular access

Disqualifiers

Known or apparent age <18 years

Initial recorded cardiac rhythm of VF or pulseless VT, or, AED shock on first analysis administered or confirmed by paramedics

Cardiac arrest due to an obvious non-cardiac primary cause (e.g. blunt or penetrating trauma, exsanguination, burns, drug overdose, drowning, anaphylaxis, sudden asphyxiation, etc.)

Administration of intramuscular, endotracheal tube, or intraosseous epinephrine

Trial design

Design model

Parallel

Treatments tested in this trial

  • Epinephrine

    Drug

    Epinephrine 1mg 1:10000 (10cc) per dose

Treatment groups

1,250 Participants
are divided into 2 treatment groups
Group A: Low Dose EpinephrineActive comparator 1 intervention
Group B: Standard Dose EpinephrineActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Survival to hospital discharge

Individuals discharged alive from hospital

Time frame
Through study completion (up to 5 years)

Secondary outcomes

1

Return of spontaneous circulation in out-of-hospital setting

Return of spontaneous circulation in the field

Time frame
Through study completion (up to 5 years)
2

Survival to emergency department arrival

Individuals alive upon arrival to a hospital emergency department

Time frame
Through study completion (up to 5 years)
3

Survival to admission with death prior to discharge

Individuals alive upon hospital admission who die in-hospital before being discharged

Time frame
Through study completion (up to 5 years)
4

Survival to discharge outside of a long-term healthcare facility e.g. nursing home

Individuals discharged alive from hospital to a care facility

Time frame
Through study completion (up to 5 years)

Other outcomes

Sponsors and contacts

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Unity Health Toronto

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator