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

3 août 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Biologique: Serum

Description détaillée

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

Type d'étude

Interventionnel

Inscription (Estimé)

210

Phase

N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

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

Sauvegarde des contacts de l'étude

Nom: Sarah BENGHANEM, Dr
Numéro de téléphone: +33 01 58 41 25 25
E-mail: sarah.benghanem@aphp.fr

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

Adulte
Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Objectif principal: Diagnostique
Répartition: N / A
Modèle interventionnel: Affectation à un seul groupe
Masquage: Aucun (étiquette ouverte)

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Cognitive function impairment assessed by the Montreal Cognitive Assessment (MoCA) score at 3 months Délai: 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

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
Coma- and/or delirium-free days Délai: Day 10 after inclusion		Day 10 after inclusion
Duration of delirium in the intensive care unit (ICU) Délai: 3 months		3 months
Type of ICU delirium: hypoactive, hyperactive, or mixed Délai: 3 months		3 months
Psychiatric disorders (anxiety, depression : ( 0 =min; 21 =max) , or PTSD) Délai: 3 months		3 months
Glasgow Outcome Scale-Extended (GOSE) Délai: 3 months		3 months
Delirium duration Délai: 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 Délai: 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 Délai: 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 Délai: 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) Délai: 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 Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Assistance Publique - Hôpitaux de Paris

Collaborateurs

URC-CIC Paris Descartes Necker Cochin

ANR and Ministry of Health

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 septembre 2026

Achèvement primaire (Estimé)

1 mai 2028

Achèvement de l'étude (Estimé)

1 août 2028

Dates d'inscription aux études

Première soumission

26 mars 2026

Première soumission répondant aux critères de contrôle qualité

3 août 2026

Première publication (Réel)

4 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)