Cardiac Arrest
Conditions
Brief 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 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.
Interventions
DRUGAmiodarone Hydrochloride Injection
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.
OTHERUsual Care Protocol
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.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | up to 1 day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | up to 1 day | — |
| The number and proportion of patients surviving to be admitted to inpatient services after arrival to the emergency department | 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 | up to 30 days | — |
| The number and proportion of patients receiving the initial dose of amiodarone from emergency medical services before the third shock from a defibrillator | up to 1 day | — |
| 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 | 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. |
| Number and proportion of participants with adverse events | up to 1 day | e.g.: malignant cardiac arrhythmia, allergic reaction, recurrent cardiac arrest |
| 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 | 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. |
Countries
United States
Contacts
Primary ContactJoshua Lupton, MD, MPH
Outcome results
None listed