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Идёт набор NCT04675918

Pediatric In-Hospital Cardiac Arrest International Registry (PACHIN)

— Наблюдательное Cardiac Arrest Pediatric ALL In-hospital Cardiac Arrest

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: Cardiac arrest.
Кому может быть актуально
Состояния в реестре: Cardiac Arrest, Pediatric ALL, In-hospital Cardiac Arrest. Базовые параметры: 1 мес. — 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
Испания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Pediatric In-Hospital Cardiac Arrest International Registry (PACHIN): a Prospective International Multicenter Register of Cardiac Arrest in Children.

Обзор

: An intrahospital CA data recording protocol has been designed following the Utstein model. Database is hosted according to European legislation regarding patient data protection. It is drafted in English and Spanish. Invitation to participate has been sent to Spanish, European and Latinamerican hospitals. Variables included, asses hospital characteristics, the resuscitation team, patient's demographics and background, CPR, post-resuscitation care, mortality, survival and long-term evolution. Survival at hospital discharge will be evaluated as a primary outcome and survival with good neurological status as a secondary outcome, analyzing the different factors involved in them

Подробное описание

Study design: this study is a multicenter, international, prospective observational registry.

Setting: patients will be enrolled by participating investigators from European and Latinamerican countries. All sites are susceptible of treating pediatric cardiac arrest patients. Participating hospitals differ in levels of care but are all able to submit their data to the study's database.

Patient elegibility: Inclusion criteria: all children aged 1 month to 18 years who suffer a CA in hospital. For the study, CA is defined as the absence of vital signs requiring at least one minute of chest compressions. Subsequent episodes of CA may be included for the same individual.

Exclusion criteria: Patients being treated with extracorporeal circulatory support (ECMO or ventricular assistance) at the time of CA. Patients who suffer a cardiac arrest and require ECMO for ROSC, after performing conventional CPR, will not be excluded. Duration of the data collection period 24 months.

Recruitment: Study candidates will be identified by a study physician, who will explain the study to parents or guardians. Written informed consent will be obtained from parents or guardians prior to inclusion in the study. A CONSORT (Consolidated Standard of Reporting Trials) flow diagram is shown in Figure 1.

Data collection: data will be collected, verified, and uploaded to a protected electronic web-based database (Xolomon) by their designated site coordinators/investigators under the oversight of their IRB. Database has been designed following the Utstein model (19). Database is hosted according to European legislation regarding patient data protection. It is drafted in English and Spanish.

Вмешательства

  • Процедура Cardiac arrest
    Definition of characteristics of cardiac arrest and resuscitation as well as post-resuscitational care and follow up.

Первичные конечные точки

  • Survival [Срок оценки: Through study completition an average of 3 years]
Вторичные конечные точки (1)
  • Neurological outcome [Срок оценки: 5 years]

Критерии участия

Критерии включения

  • all children aged 1 month to 18 years who suffer a CA in hospital

Критерии исключения

  • Patients being treated with extracorporeal circulatory support (ECMO or ventricular assistance) at the time of CA.
  • Duration of resuscitation < 1minute

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Испания · 1 центр
  • Gregorio Marañon Hospital — Madrid

Публикации

  • Del Castillo J, Sanz D, Herrera L, Lopez-Herce J; Grupo de Estudio de Parada Cardiaca Intrahospitalaria en la Infancia. Pediatric In-Hospital Cardiac Arrest International Registry (PACHIN): protocol for a prospective international multicenter register of cardiac arrest in children. BMC Cardiovasc Disord. 2021 Jul 31;21(1):365. doi: 10.1186/s12872-021-02173-5. PMID 34332522

Идентификаторы

NCT: NCT04675918 · ESCE-RCP 2.0 · PI18/01632

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗