Оценка шкалы клинической слабости (CFS) как фактора риска смертности у взрослых пациентов в возрасте до 65 лет, госпитализированных в реанимацию по поводу септического шока. (Woodstock)
The aim of the study is to demonstrate that "frail" patients, defined as having a CFS score greater than or equal to 5, and "severely" frail patients, defined as having a CFS score between [6-7] as defined by Bagshaw et al (14), constitute an independent risk factor (RF) for mortality.
In the same way, as an exploratory study, we will try to find out whether clinical frailty constitutes a risk factor for extending the length of hospital stay, the risk of short/medium-term readmission, as has already been demonstrated for patients admitted to intensive care from all causes (15), or for impaired quality of life.
The objective is to have a better understanding of the implications and outcomes associated with pre-hospital frailty in young critically ill patients.
This analysis will also help to clarify prognoses and contribute to better decision-making on the intensity and proportionality of care, as well as providing better information and helping to manage the expectations of patients and their families in terms of survival prognosis and subsequent quality of life.
Обзор исследования
Статус
Условия
Подробное описание
Recent studies show the impact of frailty in a middle-aged or even young population of patients admitted to critical care in terms of mortality (13), and the persistent risk of impairment of physical and mental capacities after resuscitation (14). To date, few studies have looked at clinical frailty as a risk factor for mortality in a middle-aged or young population, more specifically those suffering from septic shock, which is already known to be a major factor in morbidity and mortality (15,16), with repercussions on long-term quality of life.
The aim of the study is to demonstrate that "frail" patients, defined as having a CFS score greater than or equal to 5, and "severely" frail patients, defined as having a CFS score between [6-7] as defined by Bagshaw et al (14), constitute an independent risk factor (RF) for mortality.
In the same way, as an exploratory study, we will try to find out whether clinical frailty constitutes a risk factor for extending the length of hospital stay, the risk of short/medium-term readmission, as has already been demonstrated for patients admitted to intensive care from all causes (15), or for impaired quality of life.
The objective is to have a better understanding of the implications and outcomes associated with pre-hospital frailty in young critically ill patients.
This analysis will also help to clarify prognoses and contribute to better decision-making on the intensity and proportionality of care, as well as providing better information and helping to manage the expectations of patients and their families in terms of survival prognosis and subsequent quality of life.
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Контакты исследования
- Имя: MELANIE VERLAY
- Номер телефона: 03.21.69.10.28
- Электронная почта: mverlay@ch-lens.fr
Учебное резервное копирование контактов
- Имя: Guillaume DEGOUY, Dr
- Номер телефона: 03.21.69.12.34
- Электронная почта: gdegouy@ch-lens.fr
Места учебы
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Boulogne-sur-Mer, Франция, 62321
- Рекрутинг
- CH Boulogne sur Mer
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Главный следователь:
- Charles DETOLLENAERE, Dr
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Béthune, Франция, 62408
- Рекрутинг
- Ch Germon Et Gauthier
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Главный следователь:
- Ghada SBOUI, Dr
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Dijon, Франция, 21079
- Рекрутинг
- CHU de Dijon
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Главный следователь:
- Jean-Pierre QUENOT, Pr
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Lens, Франция
- Рекрутинг
- CH de Lens
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Главный следователь:
- Guillaume DEGOUY, Doctor
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Lille, Франция, 59037
- Рекрутинг
- CHU Lille
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Главный следователь:
- Alexandre GAUDET, Dr
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
All patients admitted to intensive care will be studied for this study. Patients meeting the inclusion criteria and with no non-inclusion criteria will be included in the study after obtaining the patient's or relative's, if applicable, non-objection.
Описание
Inclusion Criteria:
- Patients aged ≥18 years and ≤ 65 years
- Patient admitted to intensive care - resuscitation
- Patient admitted for suspected or documented type 3 sepsis
- Presence of vasopressor amines to maintain MAP > 65mmHg despite filling
- Lactatemia ≥ 2 mmol/L on admission.
Exclusion Criteria:
- Patient moribund on admission
- Patients with severe pre-existing dementia and/or cognitive decline, suffering from severe neurodegenerative diseases that prevent the patient from living independently at baseline, including mental illness requiring institutionalisation, including acquired or congenital mental retardation, etc.
- Pregnant women or women in labour
- Patients under guardianship or curatorship
- Patients deprived of their liberty
- Patient and/or family unable to speak or understand French.
Учебный план
Как устроено исследование?
Детали дизайна
- Наблюдательные модели: OTHER
- Временные перспективы: PROSPECTIVE
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
To show that the frailty score on admission is a risk factor for mortality at D28, independent of known risk factors, in young patients admitted to intensive care (ICU) for sepsis or septic shock.
Временное ограничение: 28 days after inclusion
|
The odds ratio of frail patients to non-frail patients for the risk of all-cause death at D28 |
28 days after inclusion
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
To study the association, independently of known risk factors, between the frailty score on admission and mortality at day 90.
Временное ограничение: 90 days after inclusion
|
Time from admission to death or last news, censored at D90 |
90 days after inclusion
|
|
To study the association, independently of known risk factors, between the frailty score on admission and length of hospital stay
Временное ограничение: 90 days after inclusion
|
The time between admission to IS and live discharge from hospital, death is considered a concurrent risk, the data are censored at 90 days |
90 days after inclusion
|
|
To study the association, independently of known risk factors, between the frailty score on admission and the number of days with recourse to invasive therapies
Временное ограничение: 90 days after inclusion
|
Number of days with mechanical ventilation, with amines, with recourse to extra-renal purification (EER) during the IS stay. |
90 days after inclusion
|
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To study the association, independently of known risk factors, between the frailty score on admission and readmission to critical care or hospitalisation before D90, among patients discharged alive from ICU before D90.
Временное ограничение: 90 days after inclusion
|
Readmission to critical care or hospitalisation before D90, among patients discharged alive from ICU before D90. |
90 days after inclusion
|
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To study the association, independently of known risk factors, between the frailty score on admission and describe changes in frailty between ICU admission and D90 in patients alive at D90.
Временное ограничение: 90 days after inclusion
|
Change in frailty score defined by the CFS (continuous) between admission and D90 (in hospital or at home). |
90 days after inclusion
|
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To study the association, independently of known risk factors, between the frailty score on admission and describe quality of life at D90 in patients alive at D90.
Временное ограничение: 90 days after inclusion
|
Quality of life measured by the EQ5D score at D90 (in hospital or at home). |
90 days after inclusion
|
Соавторы и исследователи
Спонсор
Соавторы
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 2023-02
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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