SepsisSEPSYMNCT07746050
Value of Biomarkers of Brain Injury for Predicting Psycho-cognitive Sequelae Secondary to Sepsis: a Prospective Multicenter Study
A study testing Serum in people with Sepsis and Septic Shock, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sepsis, Septic Shock
- What is being tested?
- Serum
- How many people
- 210 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2026to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hôpital Cochin - APHP Centre
Paris, Île-de-France Region, 75014
Sarah BENGHANEM, Dr, 01 58 41 25 25 ext. +33, sarah.benghanem@aphp.fr
About this study
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.
Read the detailed description
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
- Conditions
- Sepsis, Septic Shock
- Being tested
- Serum
- Keywords
- Sepsis, Delirium, Post intensive care syndrome, Biomarkers, NSE, NFL
- Medical subject headings
- Sepsis, Shock, Septic, Delirium, postintensive care syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SerumBiological
Neurofilament light chain NfL, brain-derived tau, GFAP, UCHL1, p-tau217, s100B, neurone specific enolase NSE, sTREM2, YKL-40
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (11)
Coma- and/or delirium-free days
Measured: Day 10 after inclusion
Duration of delirium in the intensive care unit (ICU)
Measured: 3 months
Type of ICU delirium: hypoactive, hyperactive, or mixed
Measured: 3 months
Psychiatric disorders (anxiety, depression : ( 0 =min; 21 =max) , or PTSD)
Measured: 3 months
Glasgow Outcome Scale-Extended (GOSE)
Measured: 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.
Measured: 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.
Measured: 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
Measured: 3 months
Functional outcome
Functional neurological outcome assessed using the Glasgow Outcome Scale-Extended (GOSE; range 1-8, higher scores indicate better functional recovery).
Measured: 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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin, ANR and Ministry of Health
- Responsible party
- Sponsor
- Investigators
- Sarah BENGHANEM, Dr, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07746050
- Sponsor's protocol ID
- APHP251947
- Other IDs
- IDRCB
- Acronym
- SEPSYM
- Status last verified
- Jul 2026
- First submitted
- 26 Mar 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Biomarkers of Brain Injury for Predicting Psycho-cognitive Sequelae Secondary to Sepsis: a Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT07746050
- Acronym / sponsor ID
- SEPSYM / APHP251947
- Conditions
- Sepsis, Septic Shock
- Keywords
- Sepsis, Delirium, Post intensive care syndrome, Biomarkers, NSE, NFL
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin, ANR and Ministry of Health
- Study start
- Sep 2026 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- Moribund patients.
- Age >80 years.
- Patients under legal guardianship.
- History of schizophrenia or bipolar disorder.
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SerumNeurofilament light chain NfL, brain-derived tau, GFAP, UCHL1, p-tau217, s100B, neurone specific enolase NSE, sTREM2, YKL-40 | Biological | – |
Primary outcome
Cognitive function impairment assessed by the Montreal Cognitive Assessment (MoCA) score at 3 months
Time frame: 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.
11 secondary outcomes
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
Time frame: 3 months
Delirium phenotype
Time frame: 3 months
Psychiatric outcomes
Time frame: 3 months
Functional outcome
Time frame: 3 months
PICS : Post-Intensive Care Syndrome (PICS)
Time frame: 3 months
Neurological, psychiatric, or rehabilitation follow-up proposed to the patient
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah BENGHANEM, Dr principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serum in people with Sepsis and Septic Shock, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah BENGHANEM, Dr (01 58 41 25 25 ext. +33, sarah.benghanem@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive function impairment assessed by the Montreal Cognitive Assessment (MoCA) score at 3 months (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.