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Идёт набор NCT03826524

Epinephrine Dose: Optimal Versus Standard Evaluation Trial

Фаза IV С лечением Cardiac Arrest, Out-Of-Hospital Sudden Cardiac Arrest Ventricular Fibrillation Ventricular Tachycardia-Pulseless

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Epinephrine.
Кому может быть актуально
Состояния в реестре: Cardiac Arrest, Out-Of-Hospital, Sudden Cardiac Arrest, Ventricular Fibrillation, Ventricular Tachycardia-Pulseless. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

CanROC Epinephrine Dose: Optimal Versus Standard Evaluation Trial (CanROC EpiDOSE Trial)

Обзор

The objective of this randomized controlled trial is to evaluate the effectiveness of a low cumulative dose of epinephrine compared to a standard cumulative dose of epinephrine during resuscitation from ventricular fibrillation (VF) or ventricular tachycardia (VT) in adult out-of-hospital cardiac arrest (OHCA) patients.

Подробное описание

This study is designed as a prospective, multicentre, single-blinded randomized controlled trial (RCT) where eligible OHCA patients are randomized to receive a low cumulative dose of epinephrine (low dose epinephrine, up to 2mg total) or a standard cumulative dose of epinephrine (standard dose epinephrine, up to 6mg total) in a 1:1 fashion.

Eligible OHCA patients will be treated by paramedics who will initiate cardiopulmonary resuscitation (CPR) and the delivery of defibrillation shocks per paramedic agencies' treatment protocols. After one defibrillation and when feasible, paramedics will establish peripheral intravenous (IV) access, and patients will be randomly allocated to either the low dose or standard dose treatment arm. Epinephrine doses (according to treatment assignment) will be administered every 3-5 minutes, based on current guidelines and paramedic protocols, until the first return of spontaneous circulation (ROSC) is achieved or if resuscitation has been terminated by the base hospital physician. Other medications (e.g. antiarrhythmics, magnesium, beta blockers) and interventions (e.g. intubation) may be interposed as required. Follow-up will take place using a combination of administrative databases (e.g. the Discharge Abstract Database and the National Ambulatory Care Reporting System) and telephone interviews.

This RCT will evaluate a fundamental change in the treatment of OHCA. The investigators hypothesize that a low cumulative dose of epinephrine will improve patient survival to hospital discharge compared to a standard cumulative dose of epinephrine. Please feel free to contact epidose@unityhealth.to for further information.

Вмешательства

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

Первичные конечные точки

  • Survival to hospital discharge [Срок оценки: Through study completion (up to 5 years)]
Вторичные конечные точки (12)
  • Return of spontaneous circulation in out-of-hospital setting [Срок оценки: Through study completion (up to 5 years)]
  • Survival to emergency department arrival [Срок оценки: Through study completion (up to 5 years)]
  • Survival to admission with death prior to discharge [Срок оценки: Through study completion (up to 5 years)]
  • Survival to discharge outside of a long-term healthcare facility e.g. nursing home [Срок оценки: Through study completion (up to 5 years)]
  • Modified Rankin Scale (mRS) score [Срок оценки: 12+/-3 months]
  • Health Utility Index-3 (HUI-3) score [Срок оценки: 12+/-3 months]
  • Hospital Anxiety and Depression Scale score [Срок оценки: 12+/-3 months]
  • Length of stay in hospital [Срок оценки: Through study completion (up to 5 years)]
  • Length of stay in critical care unit [Срок оценки: Through study completion (up to 5 years)]
  • Survival post-arrest [Срок оценки: Up to 5 years]
  • Recurrent cardiac arrest(s) [Срок оценки: Up to 5 years]
  • ICD implant post-arrest [Срок оценки: Up to 5 years]

Критерии участия

Критерии включения

  • Out-of-hospital cardiac arrest treated by paramedics
  • Initial recorded cardiac rhythm of VF or pulseless VT, or, AED shock on first analysis administered or witnessed by EMS (paramedic or fire)
  • Established intravenous vascular access

Критерии исключения

  • 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
  • Prisoners or persons in police custody
  • Known allergy or sensitivity to epinephrine

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
Тройное слепое
Основная цель
Лечение

Центры проведения

Канада · 8 центров
  • British Columbia Emergency Health Services (BCEHS) — Victoria
  • Peel Regional Paramedic Services — Brampton
  • Middlesex-London Paramedic Service — London
  • Halton Region Paramedic Services — Oakville
  • Ottawa Paramedic Services — Ottawa
  • Superior North Emergency Medical Services — Thunder Bay
  • Essex-Windsor Emergency Health Services — Windsor
  • Medavie Health Services West — Saskatoon

Идентификаторы

NCT: NCT03826524 · EpiDOSE Protocol Version 3.0

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗