Early Amiodarone in Shockable Cardiac Arrest

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Amiodarone 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 a
• Другое Usual 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 amiodaron

Первичные конечные точки

• 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 [Срок оценки: up to 1 day]

Вторичные конечные точки (7)

• The number and proportion of patients receiving the initial dose of amiodarone from emergency medical services before the third shock from a defibrillator [Срок оценки: 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 [Срок оценки: up to 1 day]
• The number and proportion of patients surviving to be admitted to inpatient services after arrival to the emergency department [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: up to 1 day]
• Number and proportion of participants with adverse events [Срок оценки: up to 1 day]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Oregon Health & Sciences University — Portland

Идентификаторы

NCT: NCT06680869 · STUDY00026455 · 1K23HL173647-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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