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

NCT07746050 | Not Yet Recruiting

• 2 other identifiers: APHP251947IDRCB
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sepsis; Septic Shock

Keywords

Sepsis; Delirium; Post intensive care syndrome; Biomarkers; NSE; NFL

Outcome Measures

Primary Outcomes (1)

• Cognitive function impairment assessed by the Montreal Cognitive Assessment (MoCA) score at 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

Secondary Outcomes (11)

• Coma- and/or delirium-free days

  Day 10 after inclusion

• Duration of delirium in the intensive care unit (ICU)

  3 months

• Type of ICU delirium: hypoactive, hyperactive, or mixed

  3 months

• Psychiatric disorders (anxiety, depression : ( 0 =min; 21 =max) , or PTSD)

  3 months

• Glasgow Outcome Scale-Extended (GOSE)

  3 months

Interventions

Serum BIOLOGICAL

Neurofilament light chain NfL, brain-derived tau, GFAP, UCHL1, p-tau217, s100B, neurone specific enolase NSE, sTREM2, YKL-40

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Moribund patients.
• Age \>80 years.
• Patients under legal guardianship.
• History of schizophrenia or bipolar disorder.
• Pregnancy.
• No health insurance coverage.
• Refusal to participate.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator
• ANR and Ministry of Health: collaborator

Study Sites (1)

Hôpital Cochin - APHP Centre

Paris, Île-de-France Region, 75014, France

Location

MeSH Terms

Conditions

Sepsis; Shock, Septic; Delirium; postintensive care syndrome

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Sarah BENGHANEM, Dr

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah BENGHANEM, Dr

CONTACT

01 58 41 25 25; sarah.benghanem@aphp.fr

Adèle BELLINO

CONTACT

01 71 76 07 57; adele.bellino@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: August 4, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)