Evaluación de la Escala de fragilidad clínica (CFS) como factor de riesgo de mortalidad en pacientes adultos ≤ 65 años ingresados en cuidados intensivos por shock séptico. (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.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Descripción detallada
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.
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Contactos y Ubicaciones
Estudio Contacto
Estudio Contacto
- Nombre: MELANIE VERLAY
- Número de teléfono: 03.21.69.10.28
- Correo electrónico: mverlay@ch-lens.fr
Copia de seguridad de contactos de estudio
- Nombre: Guillaume DEGOUY, Dr
- Número de teléfono: 03.21.69.12.34
- Correo electrónico: gdegouy@ch-lens.fr
Ubicaciones de estudio
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Boulogne-sur-Mer, Francia, 62321
- Reclutamiento
- CH Boulogne sur Mer
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Investigador principal:
- Charles DETOLLENAERE, Dr
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Béthune, Francia, 62408
- Reclutamiento
- Ch Germon Et Gauthier
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Investigador principal:
- Ghada SBOUI, Dr
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Dijon, Francia, 21079
- Reclutamiento
- CHU de Dijon
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Investigador principal:
- Jean-Pierre QUENOT, Pr
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Lens, Francia
- Reclutamiento
- CH de Lens
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Investigador principal:
- Guillaume DEGOUY, Doctor
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Lille, Francia, 59037
- Reclutamiento
- CHU Lille
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Investigador principal:
- Alexandre GAUDET, Dr
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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.
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: OTHER
- Perspectivas temporales: PROSPECTIVE
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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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.
Periodo de tiempo: 28 days after inclusion
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The odds ratio of frail patients to non-frail patients for the risk of all-cause death at D28 |
28 days after inclusion
|
Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
To study the association, independently of known risk factors, between the frailty score on admission and mortality at day 90.
Periodo de tiempo: 90 days after inclusion
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Time from admission to death or last news, censored at 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 length of hospital stay
Periodo de tiempo: 90 days after inclusion
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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
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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
Periodo de tiempo: 90 days after inclusion
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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.
Periodo de tiempo: 90 days after inclusion
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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.
Periodo de tiempo: 90 days after inclusion
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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.
Periodo de tiempo: 90 days after inclusion
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Quality of life measured by the EQ5D score at D90 (in hospital or at home). |
90 days after inclusion
|
Colaboradores e Investigadores
Patrocinador
Patrocinador
Colaboradores
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
Finalización primaria (Estimado)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- 2023-02
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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