An interventional study of Serum in Sepsis and Septic Shock, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting at 1 site in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-04.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Diagnostic
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.
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:
1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.
This study's planned enrollment of 210 is above the median of 79 across 636 interventional studies indexed under Shock, Septic.
Browse Shock, Septic studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
Compared within Shock, Septic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Sepsis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neurofilament light chain NfL, brain-derived tau, GFAP, UCHL1, p-tau217, s100B, neurone specific enolase NSE, sTREM2, YKL-40
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.
Time frame: 3 months
Coma- and/or delirium-free days
Time frame: Day 10 after inclusion
Duration of delirium in the intensive care unit (ICU)
Time frame: 3 months
Type of ICU delirium: hypoactive, hyperactive, or mixed
Time frame: 3 months
Psychiatric disorders (anxiety, depression : ( 0 =min; 21 =max) , or PTSD)
Time frame: 3 months
Glasgow Outcome Scale-Extended (GOSE)
Time frame: 3 months
Delirium duration
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.
Time frame: 3 months
Delirium phenotype
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.
Time frame: 3 months
Psychiatric outcomes
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
Time frame: 3 months
Functional outcome
Functional neurological outcome assessed using the Glasgow Outcome Scale-Extended (GOSE; range 1-8, higher scores indicate better functional recovery).
Time frame: 3 months
PICS : Post-Intensive Care Syndrome (PICS)
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.
Time frame: 3 months
Neurological, psychiatric, or rehabilitation follow-up proposed to the patient
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.
Time frame: 3 months
Plan to share: No
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