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Starting soon Not applicable

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

NCT07746050 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2026-09
Last updated
2026-08-04

Condition(s) studied

SepsisSeptic Shock

Investigational drug(s) / intervention(s)

Serum

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Cognitive function impairment assessed by the Montreal Cognitive Assessment (MoCA) score at 3 months — 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.

Trial sites (1)

FacilityCityRegionStatus
Hôpital Cochin - APHP Centre Paris Île-de-France Region
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07746050 on ClinicalTrials.gov ↗ ← All trials in France