Cardiac ArrestPhase 3Early-AmioNCT06680869
Early Amiodarone in Shockable Cardiac Arrest
A Phase 3 study testing Amiodarone Hydrochloride Injection in people with Cardiac Arrest, run by Oregon Health and Science University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- Amiodarone Hydrochloride Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 585 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2025to 31 Jan 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Oregon Health & Sciences University
Portland, Oregon, 97035
Joshua Lupton, MD, MPH, 503-418-6706, lupton@ohsu.edu
Joshua Lupton, MD, MPH
About this study
Official title: Early Amiodarone in Shockable Cardiac Arrest (Early-Amio) 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.
Read the detailed description
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.
- Conditions
- Cardiac Arrest
- Being tested
- Amiodarone Hydrochloride Injection, Usual Care Protocol
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amiodarone Hydrochloride InjectionDrug
Also called Early-Amiodarone Protocol
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 ProtocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Early Amiodarone Protocol | Experimental | Amiodarone administration after the second defibrillator shock, during the same two-minute cycle as the initial dose of epinephrine. Receives: Drug: Amiodarone Hydrochloride Injection |
| Usual Care Protocol | Active comparator | Amiodarone administration after the third defibrillator shock, one two-minute cycle after the initial dose of epinephrine. Receives: Other: Usual Care Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 1 day
Secondary outcomes (7)
The number and proportion of patients receiving the initial dose of amiodarone from emergency medical services before the third shock from a defibrillator
Measured: up to 1 day
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
Measured: up to 1 day
The number and proportion of patients surviving to be admitted to inpatient services after arrival to the emergency department
Measured: up to 1 day
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
Measured: up to 30 days
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
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.
Measured: up to 30 days
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
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.
Measured: up to 1 day
Number and proportion of participants with adverse events
e.g.: malignant cardiac arrhythmia, allergic reaction, recurrent cardiac arrest
Measured: up to 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start1 Jan 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 585 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Joshua Lupton, Oregon Health and Science University
- Investigators
- Joshua Lupton, MD, MPH, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06680869
- Sponsor's protocol ID
- STUDY00026455
- Other IDs
- 1K23HL173647-01
- Acronym
- Early-Amio
- Status last verified
- Dec 2025
- First submitted
- 5 Nov 2024
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: A de-identified dataset will be shared with all data elements required for analysis, if de-identification is deemed feasible, with the NHLBI BioLINCC.
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Amiodarone in Shockable Cardiac Arrest (Early-Amio) Study
- ClinicalTrials.gov ID
- NCT06680869
- Acronym / sponsor ID
- Early-Amio / STUDY00026455
- Conditions
- Cardiac Arrest
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 585 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 8 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Amiodarone Protocol | Experimental | Drug: Amiodarone Hydrochloride InjectionAmiodarone administration after the second defibrillator shock, during the same two-minute cycle as the initial dose of epinephrine. |
| Usual Care Protocol | Active comparator | Other: Usual Care ProtocolAmiodarone administration after the third defibrillator shock, one two-minute cycle after the initial dose of epinephrine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amiodarone Hydrochloride InjectionAlso: Early-Amiodarone ProtocolThe 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. | Drug | Early Amiodarone Protocol |
| Usual Care ProtocolThe 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. | Other | Usual Care Protocol |
Primary outcome
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
7 secondary outcomes
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
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
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
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
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
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
Number and proportion of participants with adverse events
Time frame: up to 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Early-Amio Study WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. A de-identified dataset will be shared with all data elements required for analysis, if de-identification is deemed feasible, with the NHLBI BioLINCC.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joshua Lupton, MD, MPH principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Amiodarone Hydrochloride Injection in people with Cardiac Arrest, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joshua Lupton, MD, MPH ((503) 418-6706, lupton@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.