Ensaio clínico em Choque Séptico, Fragilidade - Registro de Ensaios Clínicos

Visão geral do estudo

Status

Recrutamento

Condições

Descrição detalhada

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 estudo

Observacional

Inscrição (Estimado)

200

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Nome: MELANIE VERLAY
Número de telefone: 03.21.69.10.28
E-mail: mverlay@ch-lens.fr

Estude backup de contato

Nome: Guillaume DEGOUY, Dr
Número de telefone: 03.21.69.12.34
E-mail: gdegouy@ch-lens.fr

Locais de estudo

França
- - Boulogne-sur-Mer, França, 62321
    - Recrutamento
    - CH Boulogne sur Mer
    - Investigador principal:
      
      Charles DETOLLENAERE, Dr
  - Béthune, França, 62408
    - Recrutamento
    - Ch Germon Et Gauthier
    - Investigador principal:
      
      Ghada SBOUI, Dr
  - Dijon, França, 21079
    - Recrutamento
    - CHU de Dijon
    - Investigador principal:
      
      Jean-Pierre QUENOT, Pr
  - Lens, França
    - Recrutamento
    - CH de Lens
    - Investigador principal:
      
      Guillaume DEGOUY, Doctor
  - Lille, França, 59037
    - Recrutamento
    - CHU Lille
    - Investigador principal:
      
      Alexandre GAUDET, Dr

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 65 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Modelos de observação: OTHER
Perspectivas de Tempo: PROSPECTIVE

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
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. Prazo: 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

Medidas de resultados secundários

Medida de resultado	Descrição da medida	Prazo
To study the association, independently of known risk factors, between the frailty score on admission and mortality at day 90. Prazo: 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 Prazo: 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 Prazo: 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
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. Prazo: 90 days after inclusion	Readmission to critical care or hospitalisation before D90, among patients discharged alive from ICU before D90.	90 days after inclusion
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. Prazo: 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
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. Prazo: 90 days after inclusion	Quality of life measured by the EQ5D score at D90 (in hospital or at home).	90 days after inclusion

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Centre Hospitalier de Lens

Colaboradores

University Hospital, Lille

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

21 de agosto de 2023

Conclusão Primária (Estimado)

18 de setembro de 2027

Conclusão do estudo (Estimado)

1 de novembro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

26 de junho de 2023

Enviado pela primeira vez que atendeu aos critérios de CQ