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Идёт набор NCT06671795

ICU Biobank: Understanding Post-Intensive Care Syndrome (PICS)

— Наблюдательное Post-Intensive Care Syndrome (PICS)

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: Post-Intensive Care Syndrome (PICS). Базовые параметры: 18 лет — 65 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
Австрия
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

Improving Intensive Care Through Biobanking: a Strategic Approach to Understanding Post-Intensive Care Syndrome

Обзор

The goal of this observational study is to explore the development and progression of Post-Intensive Care Syndrome (PICS) in adult ICU patients by establishing a biobank of biological samples and outcome data. This biobank-based research is designed to investigate the physical, cognitive, and psychological health outcomes of ICU survivors and their relationship with potential biomarkers. The study population includes adult ICU patients aged 18-65, who have stayed in the ICU for at least 48 hours. The main questions it aims to answer are: What is the incidence of PICS and its main components? What risk factors are associated with the development of PICS six months post-ICU discharge? What are the long-term effects of ICU admission on quality of life, cognitive health, and physical function? Participants will: Provide blood samples during ICU admission and at follow-up visits at 4-5 weeks, 6 months, and 10-12 months after discharge. Complete assessments measuring quality of life, cognitive health, anxiety, depression, PTSD symptoms, physical function, and pulmonary function. Participate in three follow-up visits at the ICU Recovery Clinic after discharge to monitor PICS symptoms and recovery progress. This study does not involve an intervention but will gather data that could improve our understanding of PICS and inform strategies for post-ICU care. The data collected will be crucial for identifying PICS biomarkers and will contribute to developing targeted, personalized interventions for ICU survivors in the future.

Первичные конечные точки

  • Incidence of PICS and its components [Срок оценки: at 4-5 weeks, 6 months and 10-12 months after ICU discharge]
  • Health-related quality of life (HRQoL) using EQ-5D-5L [Срок оценки: at 4-5 weeks, 6 months and 10-12 months after ICU discharge]
  • Health-Related Quality of Life (HRQoL) using SF-36 [Срок оценки: at 4-5 weeks, 6 months and 10-12 months after ICU discharge]
  • Cognitive Function using Montreal Cognitive Assessment (MoCA) [Срок оценки: at 4-5 weeks, 6 months and 10-12 months after ICU discharge]
  • Cognitive Function using Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) [Срок оценки: at 4-5 weeks, 6 months and 10-12 months after ICU discharge]
  • Anxiety and Depression Symptoms using HADS [Срок оценки: at 4-5 weeks, 6 months and 10-12 months after ICU discharge]
  • Post-traumatic stress disorder (PTSD) symptoms using Impact of Event Scale-Revised (IES-R) [Срок оценки: at 4-5 weeks, 6 months and 10-12 months after ICU discharge]
  • Physical Function using 6-Minute Walk Test (6MWT) [Срок оценки: at 4-5 weeks, 6 months and 10-12 months after ICU discharge]
  • Physical Function using using Chelsea Critical Care Physical Assessment Tool (CPAx) [Срок оценки: at 4-5 weeks, 6 months and 10-12 months after ICU discharge]
  • Pulmonary Function - FEV1/FVC Ratio [Срок оценки: at 4-5 weeks, 6 months and 10-12 months after ICU discharge]
Вторичные конечные точки (2)
  • Pain and Discomfort using EQ-5D-5L [Срок оценки: 4-5 weeks, 6 months and 10-12 months after ICU discharge]
  • Frailty Status using Clinical Frailty Scale [Срок оценки: 4-5 weeks, 6 months and 10-12 months after ICU discharge]

Критерии участия

Критерии включения

  • ICU stay of at least 48 hours
  • Age between 18 and 65 years at the time of ICU admission
  • Written informed consent

Критерии исключения

  • Transfer from another ICU outside of the Medical University of Vienna
  • Patient with a legal guardian
  • Homelessness
  • Place of residence outside of Austria

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Австрия · 1 центр
  • Medical University of Vienna — Vienna

Идентификаторы

NCT: NCT06671795 · SASICUPICS2012/2023 · 101132808

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗