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Value of Biomarkers of Brain Injury for Predicting Psycho-cognitive Sequelae Secondary to Sepsis: a Prospective Multicenter Study (SEPSYM)

3 de agosto de 2026 atualizado por: Assistance Publique - Hôpitaux de Paris

To evaluate the value of biomarkers of neuronal and glial injury for predicting cognitive impairment (memory impairment assessed by a MoCA score < 26/30) at 3 months in patient admitted in the intensive care unit for a sepsis or a septic shock.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Biológico: Serum

Descrição detalhada

Sepsis is a major cause of admission to intensive care units and is responsible for approximately 11 million deaths worldwide each year. It may be complicated by an acute brain dysfunction known as sepsis-associated encephalopathy (SAE), which affects about 50% of patients and typically manifests as delirium or coma. The diagnosis of SAE is primarily clinical, with EEG and brain MRI providing supportive information. Risk factors for SAE are mainly related to patient characteristics, including advanced age, chronic kidney disease, and pre-existing neurodegenerative or cognitive disorders. The pathophysiology of SAE involves three major mechanisms: neuroinflammation, endothelial dysfunction with blood-brain barrier disruption, and mitochondrial dysfunction leading to neuronal injury. These mechanisms likely explain both acute neurological symptoms and long-term psycho-cognitive sequelae. Following sepsis, 30-60% of patients develop psychiatric disorders and cognitive impairments comparable to those observed after moderate traumatic brain injury or early Alzheimer's disease. These sequelae are part of post-intensive care syndrome (PICS), supporting the need for structured post-ICU follow-up. However, the optimal target population and organization of such follow-up remain unclear, as some studies have reported reduced quality of life in patients receiving long-term follow-up. Identifying early biomarkers predictive of psycho-cognitive outcomes is therefore crucial, as current data on neuronal and glial biomarkers remain limited. Such biomarkers could improve prognostication, guide cognitive rehabilitation and psychological support, and contribute to the development of future neuroprotective strategies.

Primary objective:

To evaluate the value of biomarkers of brain injury for predicting cognitive impairment (memory impairment assessed by a MoCA score < 26/30) at 3 months.

Secondary objectives:

To evaluate the value of brain injury biomarkers for predicting delirium in the ICU, including hypoactive, hyperactive, and mixed phenotypes
To assess the association between brain injury biomarkers and the duration of delirium in the ICU
To evaluate the value of brain injury biomarkers for predicting psychological sequelae (anxiety, post-traumatic stress disorder, and depression) at 3 months
To evaluate the value of brain injury biomarkers for predicting functional neurological outcomes using the Glasgow Outcome Scale-Extended at ICU discharge and at 3 months
To assess the association between brain injury biomarkers and Post-Intensive Care Syndrome (PICS)
To assess the association between brain injury biomarkers and EEG abnormalities in the ICU
To assess the association between brain injury biomarkers and MRI abnormalities at 3 months

Tipo de estudo

Intervencional

Inscrição (Estimado)

210

Estágio

Não aplicável

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: Adèle BELLINO
Número de telefone: +33 01 71 76 07 57
E-mail: adele.bellino@aphp.fr

Estude backup de contato

Nome: Sarah BENGHANEM, Dr
Número de telefone: +33 01 58 41 25 25
E-mail: sarah.benghanem@aphp.fr

Locais de estudo

França
- Île-de-France Region
  - Paris, Île-de-France Region, França, 75014
    - Hôpital Cochin - APHP Centre
    - Contato:
      
      Sarah BENGHANEM, Dr
      
      Número de telefone: +33 01 58 41 25 25
      
      E-mail: sarah.benghanem@aphp.fr

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

Adulto
Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

Adults aged 18-80 years.
Admission to a medical or mixed ICU.
Sepsis or septic shock according to Sepsis-3 criteria.
ICU admission for less than 24 hours.
Need for invasive or non-invasive mechanical ventilation and/or vasopressor support.
Informed consent obtained from the patient or legal representative.

Exclusion Criteria:

Moribund patients.
Age >80 years.
Patients under legal guardianship.
History of schizophrenia or bipolar disorder.
Pregnancy.
No health insurance coverage.
Previous inclusion in the study.
Refusal to participate.

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

Finalidade Principal: Diagnóstico
Alocação: N / D
Modelo Intervencional: Atribuição de grupo único
Mascaramento: Nenhum (rótulo aberto)

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
Cognitive function impairment assessed by the Montreal Cognitive Assessment (MoCA) score at 3 months Prazo: 3 months	Montreal Cognitive Assessment (MoCA) ranges from 0 to 30 points, with higher scores indicating better cognitive performance. Cognitive impairment will be defined as a MoCA score <26/30.	3 months

Medidas de resultados secundários

Medida de resultado	Descrição da medida	Prazo
Coma- and/or delirium-free days Prazo: Day 10 after inclusion		Day 10 after inclusion
Duration of delirium in the intensive care unit (ICU) Prazo: 3 months		3 months
Type of ICU delirium: hypoactive, hyperactive, or mixed Prazo: 3 months		3 months
Psychiatric disorders (anxiety, depression : ( 0 =min; 21 =max) , or PTSD) Prazo: 3 months		3 months
Glasgow Outcome Scale-Extended (GOSE) Prazo: 3 months		3 months
Delirium duration Prazo: 3 months	Number of ICU days with delirium assessed using the Confusion Assessment Method for the ICU (CAM-ICU). Delirium duration will be reported as the cumulative number of ICU days with at least one positive CAM-ICU assessment. Higher values indicate longer delirium duration.	3 months
Delirium phenotype Prazo: 3 months	ICU delirium phenotype classified as hypoactive, hyperactive or mixed according to CAM-ICU and RASS assessments. Results will be reported as the proportion of patients in each category.	3 months
Psychiatric outcomes Prazo: 3 months	Symptoms of anxiety and depression assessed using the Hospital Anxiety and Depression Scale (HADS; higher scores indicate greater symptom severity). PTSD assessed using the PTSD Checklist (PCL-5). Results will be reported as continuous scores and proportions of patients above validated thresholds	3 months
Functional outcome Prazo: 3 months	Functional neurological outcome assessed using the Glasgow Outcome Scale-Extended (GOSE; range 1-8, higher scores indicate better functional recovery).	3 months
PICS : Post-Intensive Care Syndrome (PICS) Prazo: 3 months	PICS is defined by the presence of cognitive impairment, psychiatric symptoms and/or physical disability at 3 months. Results will be reported as the proportion of patients fulfilling at least one PICS domain.	3 months
Neurological, psychiatric, or rehabilitation follow-up proposed to the patient Prazo: 3 months	Referral for specialized follow-up after ICU discharge. This outcome will be reported as the proportion of patients referred to neurological consultation, psychiatric consultation, cognitive rehabilitation, physical rehabilitation and/or a multidisciplinary post-ICU clinic.	3 months

Colaboradores e Investigadores

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

Patrocinador

Assistance Publique - Hôpitaux de Paris

Colaboradores

URC-CIC Paris Descartes Necker Cochin

ANR and Ministry of Health

Investigadores

Investigador principal: Sarah BENGHANEM, Dr, Assistance Publique - Hôpitaux de Paris

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 (Estimado)

1 de setembro de 2026

Conclusão Primária (Estimado)

1 de maio de 2028

Conclusão do estudo (Estimado)

1 de agosto de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

26 de março de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

3 de agosto de 2026

Primeira postagem (Real)

4 de agosto de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)