Меню
Идёт набор NCT06048796

Early Cessation of Sedation and TTM in Patients With a Favourable EEG After Cardiac Arrest

Без фазы С лечением Hypoxia-Ischemia, Brain Heart 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: Early cessation of sedation and TTM.
Кому может быть актуально
Состояния в реестре: Hypoxia-Ischemia, Brain, Heart Arrest. 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
Нидерланды
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Early Cessation of Sedation and TTM in Patients With a Favourable EEG After Cardiac Arrest: a Feasibility and Safety Study

Обзор

The objective of this study is to estimate the feasibility and safety of early weaning from ICU treatment in patients after cardiac arrest and an early (\< 12 h) favourable EEG pattern (indicating no or mild postanoxic encephalopathy).

Подробное описание

Comatose patients after cardiac arrest are treated on intensive care units with sedative medication, targeted temperature management (TTM), mechanical ventilation, and hemodynamic support. Despite substantial variation in the severity of the encephalopathy and even lack of unequivocal evidence of efficacy of sedation and TTM, all patients receive standard treatment. The severity of the postanoxic encephalopathy can reliably be assessed with the electroencephalogram (EEG). A continuous EEG pattern within the first 12 hours after cardiac arrest ("favorable EEG") is strongly associated with a good neurological outcome and reflects a very mild or transient encephalopathy. The investigators hypothesize that this subgroup of patients, with a favorable EEG will not benefit from prolonged sedation and TTM.

The objective of this study is to estimate the feasibility and safety of early weaning from ICU treatment in patients after cardiac arrest and an early (\< 12 h) favourable EEG pattern. The study design is a cluster randomized crossover design with two treatment arms. The intervention contrast will be early cessation of sedation and TTM, with subsequent weaning from mechanical ventilation if appropriate (intervention group) vs. standard care, including sedation and TTM for at least 24-48 hours (control group). The investigators will include forty adult patients admitted to the ICU with postanoxic encephalopathy after cardiac arrest and an early (\<12 hours) favorable EEG pattern.

Вмешательства

  • Другое Early cessation of sedation and TTM
    Early cessation of sedation and TTM, with subsequent weaning from mechanical ventilation if appropriate

Первичные конечные точки

  • Mechanical ventilation time in hours [Срок оценки: During the complete ICU admission (from admission to the ICU until discharge from the ICU, up to 30 days).]
Вторичные конечные точки (10)
  • Length of ICU stay [Срок оценки: During the complete ICU admission (from admission to the ICU until discharge from the ICU, up to 30 days).]
  • Total sedation time [Срок оценки: During the complete ICU admission (from admission to the ICU until discharge from the ICU, up to 30 days).]
  • Need for re-intubation [Срок оценки: During the complete ICU admission (from admission to the ICU until discharge from the ICU, up to 30 days).]
  • Need for restarting sedation [Срок оценки: During the complete ICU admission (from admission to the ICU until discharge from the ICU, up to 30 days).]
  • Number of serious adverse events (SAEs) [Срок оценки: at 3 and 6 months]
  • Mortality [Срок оценки: at 30 days, 3 months and 6 months]
  • Complications during intensive care admission [Срок оценки: During the complete ICU admission (from admission to the ICU until discharge from the ICU, up to 30 days).]
  • Neurological outcome measured at the Extended Glasgow Outcome Scale (GOSE) [Срок оценки: at 3 and 6 months]
  • Neurological outcome measured at the Cerebral Performance Category (CPC) [Срок оценки: at 3 and 6 months]
  • Cognitive functioning [Срок оценки: at 3 and 6 months]

Критерии участия

Критерии включения

  • Patients after cardiac arrest admitted to the ICU for treatment with sedation, TTM and mechanical ventilation.
  • Age 18 years or older.
  • Continuous EEG measurement started within 12 hours after cardiac arrest.
  • Favourable EEG pattern within 12 hours after arrest, defined as a continuous background pattern (NVN, 2019; Ruijter et al., 2019).
  • Possibility to stop sedative treatment within three hours after identification of a favourable EEG pattern.
  • Written informed consent (deferred).

Критерии исключения

  • A known history of another medical condition with limited life expectancy (<6 months).
  • Any progressive brain illness, such as a brain tumour or neurodegenerative disease.
  • Pre-admission Glasgow Outcome Scale Extended score of 4 or lower.
  • Reason other than neurological condition to continue sedation and/or ventilation.
  • Follow-up impossible due to logistic reasons.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Нидерланды · 2 центра
  • Rijnstate hospital — Arnhem
  • Medisch Spectrum Twente — Enschede

Публикации

  • Bhat N, Amorim E. Cost-Effectiveness of EEG Monitoring in Hypoxic-Ischemic Brain Injury After Cardiac Arrest. J Clin Neurophysiol. 2026 Jul 1;43(5):423-431. doi: 10.1097/WNP.0000000000001261. Epub 2026 May 7. PMID 42359664

Идентификаторы

NCT: NCT06048796 · SELECT · NL84714.100.23

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗