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Идёт набор NCT06387225

Early and Objective Assessment of Neurological Prognosis in Cardiac Arrest Patients

Наблюдательное Cardiac Arrest Neurologic Symptoms Intensive Care Neurological Disorder

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Cardiac Arrest, Neurologic Symptoms, Intensive Care Neurological Disorder. 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
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

Cerebral lesions are responsible for two thirds of deaths in patients admitted to intensive care following cardiac arrest. Patients with neurological lesions should be the priority target for neuroprotective interventions, which are the cornerstone of post-cardiac arrest care (allowing a reduction in the burden of care for patients without this type of lesion). Furthermore, these interventions must be based on a precise assessment of the severity of these brain lesions: carrying out neuro-protective interventions in patients without brain lesions exposes these patients to unnecessary treatment potentially associated with adverse effects without any possible benefit. However, the early assessment of neurological prognosis, particularly on admission to intensive care, is an area where there is little research and where it is not possible to obtain a precise and reproducible assessment. Several tools can be used to assess this prognosis at an early stage: anamnesis and characteristics of the cardiac arrest and the patient's comorbidities, imaging, electrophysiology and biomarkers. To assess the predictive value of early biomarker testing in patients resuscitated after cardiac arrest, whatever the cause, the investigators plan to conduct a prospective observational multicentre trial. It is important to bear in mind that the aim of this study is not to assess the long-term prognosis of patients suffering cardiac arrest in order to take measures to limit or discontinue active therapies, but simply to provide a reliable tool, simple and quick to use, in order to be able to identify a sub-population of patients who should be the subject of preferential neuro-protection measures, and conversely to simplify management (moderate temperature control, early cessation of sedation, early extubation) for patients with no neurological lesions.

Первичные конечные точки

  • Dosage of biomarker UCHL-1 (Ubiquitin carboxy-terminal hydrolase L1) at the time of admission to intensive care [Срок оценки: at ICU admission]
  • Dosage of biomarker GFAP (Glial fibrillary acidic protein) at the time of admission to intensive care [Срок оценки: at ICU admission]
  • Neurological outcome at D90 assessed by modified Rankin scale (mRS) [Срок оценки: 90 days after patient enrolment in the study]
Вторичные конечные точки (5)
  • Dosage of biomarkers UCHL-1 ((Ubiquitin carboxy-terminal hydrolase L1) at the time of admission to intensive care [Срок оценки: at ICU admission]
  • Dosage of biomarkers GFAP (Glial fibrillary acidic protein) at the time of admission to intensive care [Срок оценки: at ICU admission]
  • Dosage of biomarkers UCHL-1 (Ubiquitin carboxy-terminal hydrolase L1) at 4 hours for recovery of effective cardiac activity (RACS) [Срок оценки: at 4 hours for recovery of effective cardiac activity (RACS)]
  • Dosage of biomarkers GFAP( Glial fibrillary acidic protein) at 4 hours for recovery of effective cardiac activity (RACS) [Срок оценки: at 4 hours for recovery of effective cardiac activity (RACS)]
  • Neurological outcome at D90 assessed by modified Rankin scale (mRS) ranging from 0 to 6 [Срок оценки: 90 days after patient enrolment in the study]

Критерии участия

Критерии включения

  • Age ≥ 18 years
  • Admitted to intensive care with out-of-hospital cardiac arrest
  • Comatose on admission (defined by a Glasgow score ≤ 8)
  • Informed relative who has consented to the patient's participation in the study or inclusion under emergency procedure if the relative is absent at the time of inclusion

Критерии исключения

  • In-hospital cardiac arrest
  • Age < 18 years
  • Person under guardianship or legal protection
  • Prior inclusion in the study

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Франция · 4 центра
  • CHD Vendée — La Roche-sur-Yon
  • CHU Nantes — Nantes
  • APHP - Hôpital Cochin — Paris
  • CH Saint-Nazaire — Saint-Nazaire

Идентификаторы

NCT: NCT06387225 · RC23_0248

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗