Acute Respiratory Distress Syndrome (ARDS)NEURDSNCT07629973
A Study of the Determinants of Neurological Outcomes in Patients With Acute Respiratory Distress Syndrome
A study testing Blood test scores calculations in people with Acute Respiratory Distress Syndrome (ARDS) and s100b, run by University Hospital, Angers.
Trial summary
Acute respiratory distress syndrome (ARDS) is characterized by pathological pulmonary edema caused by direct or indirect damage to the alveolar-capillary membrane. Its management relies on etiological treatment, invasive mechanical ventilation, and the use of sedatives and neuromuscular blockers, depending on the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome (ARDS), s100b, Mechanical Power
- What is being tested?
- Blood test scores calculations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 17 Oct 2026to 23 Oct 2029
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient
- Patient admitted to the intensive care unit less than 48 hours ago
- Patient diagnosed with mild, moderate or severe ARDS according to the Berlin classification based on the PaO₂/FiO₂ ratio, with a minimum PEEP set at 5 cmH₂O (16), of pulmonary aetiology:
- Mild ARDS: 200 < PaO₂/FiO₂ < 300 mmHg
- Moderate ARDS: 100 < PaO₂/FiO₂ < 200 mmHg
- Severe ARDS: PaO₂/FiO₂ < 100 mmHg
Show all 9Show fewer
- Patients fitted with an oesophageal pressure measurement catheter (Nutrivent, Sidam, San Giacomo Roncole, Italy)
- Patients registered with or covered by a social security scheme
- Free and informed consent from the patient or a trusted relative (where the patient is unable to give consent).
Who cannot join
- Patients with a history of central nervous system disorders resulting in cognitive impairment
- Patients on ECMO
- Patients admitted for symptomatic central nervous system disorders
- Patients admitted for acute respiratory distress syndrome following cardiorespiratory arrest.
- Patients being treated for a psychiatric condition, chronic heavy drinkers, or those undergoing long-term treatment with benzodiazepines, antidepressants or antipsychotics.
- Pregnant, breastfeeding or labouring patients
Show all 9Show fewer
- Individuals subject to a legal protection order
- Individuals receiving compulsory psychiatric care
- Individuals deprived of their liberty by judicial or administrative decision
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Etude Des déterminants de l'évolution NEUrologique Des Patients Ayant présenté un Syndrome de Détresse Respiratoire aiguë
Acute respiratory distress syndrome (ARDS) is characterized by pathological pulmonary edema caused by direct or indirect damage to the alveolar-capillary membrane.
Its management relies on etiological treatment, invasive mechanical ventilation, and the use of sedatives and neuromuscular blockers, depending on the patient's condition.
Read more
Improvements in patient care have led to an improved prognosis. However, in-hospital mortality remains high (between 35% and 45%). Notably, morbidity among surviving patients is very high and is largely dominated by neuropsychological sequelae. Attention and executive function disorders, confusion, disorientation, or memory impairment are thus found in 70 to 100% of patients following ARDS. These disorders are still present in 46 to 80% of surviving patients one year after ARDS and in 20% of them five years later.
Although essential to treatment, mechanical ventilation carries a risk of significant complications. Beyond the risk of infection and complications related to sedation and neuromuscular blockade, the use of mechanical ventilation is associated with a risk of ventilator-induced lung injury (VILI).
The use of so-called protective ventilation reduces the risk of VILI and improves patient outcomes. However, analysis of relevant physiological parameters shows that the risk of VILI may still exist even when ventilator settings comply with recommendations and the concept of protective ventilation. Driving pressure (which represents Strain) is a good marker of VILI; it represents the distension of the lung with each breath relative to the initial lung volume. Values above 14 cmH₂O are associated with high mortality in patients with ARDS. Inspiratory transpulmonary pressure represents Stress-that is, the pressure that distends the alveoli at the end of inspiration-and is also associated with the risk of VILI. Finally, mechanical power represents the amount of energy delivered to the lung by the ventilator and has been validated as a marker of VILI. The advantage of mechanical power over the other indices described is that it incorporates all components that can lead to VILI.
Among the various sources of neurological damage during ARDS, inflammatory processes appear to play a major role. Numerous inflammatory mediators (TNF-α, IL-6, IL-8, IL-1β) are secreted during ARDS, and animal studies have demonstrated a link between inflammation and hippocampal damage. Furthermore, cerebral ischemic lesions, exacerbated by systemic inflammation and endothelial activation leading to coagulation activation with thrombus formation, may also contribute to the development of cognitive impairments.
In addition to the inflammatory processes associated with ARDS, mechanical ventilation itself may have a significant impact on neuroinflammatory damage. Recently, the term "ventilator-associated brain injury" (VABI) has been proposed to describe these secondary neurological lesions induced by mechanical ventilation. Studies in mouse and pig models have demonstrated a relationship between the dose and duration of VILI, apoptosis, neuroinflammation, and neuronal damage. An animal study in mice also showed an association between the duration of mechanical ventilation and the onset of cognitive impairments.
During brain injury, proteins and neurotransmitters are released and serve as biomarkers of brain damage. Elevated plasma levels of S100B protein indicate astrocyte damage caused by traumatic, anoxic-ischemic, or inflammatory mechanisms. It correlates with neurological prognosis following cardiac arrest, in ischemic or hemorrhagic strokes, in neurodegenerative diseases, and in patients with traumatic brain injury.
Clinical studies have shown a negative correlation between elevated S100B protein levels, the MoCA (Montreal Cognitive Assessment) score, and the MMSE (Mini-mental state evaluation ) in patients with OSA (Obstructive Sleep Apnea) or COPD (chronic obstructive pulmonary disease), respectively, indicating an association between this protein and cognitive impairment.
The investigators therefore hypothesize that mechanical ventilation associated with high mechanical power is linked to a significant risk of brain injury, reflected by elevated serum S100B protein levels and the presence of neurocognitive disorders long after ARDS.
- Conditions
- Acute Respiratory Distress Syndrome (ARDS), s100b, Mechanical Power, Ventilator Induced Lung Injury, Transpulmonary Pressure
- Being tested
- Blood test scores calculations
- Medical subject headings
- Respiratory Distress Syndrome, Ventilator-Induced Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood test scores calculationsOther
collection of oesophageal pressure data, mechanical power calculation, MOCA score collection and blood sample collection for S100B protein dosage
| Study group | Role | What they receive |
|---|---|---|
| cohort | Experimental | collection of oesophageal pressure data, mechanical power calculation, MOCA score collection and blood sample collection for S100B protein dosage Receives: Other: Blood test scores calculations |
What is being measured
The primary outcome is the main question the study is designed to answer.
association between the mechanical power between Day 1 and Day 3 (reflecting the risk of VILI)
mechanical power calculation
Measured: at day 1, day 2 and day 3
S-100B serum protein level between Day 1 (H0) and Day 3 (H72).
S-100B protein dosage
Measured: at day 1, day 2 and day 3
Secondary outcomes (9)
association between serum S100B protein concentrations from day 1 to day 3 and neurological outcome at 3 months and 12 months
Correlation coefficient between S-100B protein levels from Day 1 to Day 3 and the MOCA (Montreal Cognitive Assessment) score at 3 and 12 months (no neurocognitive impairment if MOCA ≥ 26/30, neurocognitive impairment if < 25/30).
Measured: at 3 and 12 months
association between other VILI markers (inspiratory transpulmonary pressure and driving pressure) and serum S100B protein concentrations from day 1 to day 3.
Correlation coefficient between inspiratory transpulmonary pressure and driving pressure, and serum S-100B levels between Day 1 and Day 3, whilst accounting for potential confounding factors in a multivariate model
Measured: From day 1 to day 3
association between these other VILI markers and neurological outcomes at 3 months and 12 months.
Correlation coefficient between mechanical power, inspiratory transpulmonary pressure and driving pressure (average of values measured between J1 and J3) and the MOCA score at 3 and 12 months, taking potential confounding factors into account in a multivariate model
Measured: at 3 and 12 months
association between the occurrence of delirium during a stay in the intensive care unit and neurological outcomes at 3 and 12 months.
The occurrence of neurocognitive impairment, defined as a MoCA score of <25/30 at the 3- and 12-month assessments, in patients who experienced delirium in the intensive care unit compared with those who did not.
Measured: at 3 and 12 months
prevalence of depression among patients who presented ARDS
occurrence of depressive symptoms defined as a Patient Health Questionnaire-9 (PHQ-9) score > 10/27
Measured: at 3 months
prevalence of post-traumatic stress (PCL-5 score) among patients who presented ARDS
occurrence of post-traumatic stress defined as a Post-Traumatic Stress Disorder Checklist dor DSM-5 (PCL-5) score > 33/80
Measured: at 3 months
prevalence of anxiety among patients who presented ARDS
anxiety disorders defined as a General Anxiety Disorder-2 (GAD-2) score > 3/6
Measured: at 3 months
quality of life state (Euro 5d 5l score) among patients who presented ARDS
deterioration in quality of life measured with EuroQol-5D-5L (max 5 points) :score analysed both continuously and categorically
Measured: at 3 months
prevalence of independence among patients who presented ARDS
occurence of a decline in functional independence defined as the loss of at least one instrumental activity compared with the level prior to hospitalisation with the Instrumental Activities of Daily Living (IADL) score (from 8 to 30 max)
Measured: at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start17 Oct 2026 (estimated)
- Primary completion23 Oct 2028 (estimated)
- Study completion23 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress Syndrome (ARDS)Studies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07629973
- Sponsor's protocol ID
- 49RC25_0292
- Acronym
- NEURDS
- Status last verified
- Jul 2026
- First submitted
- 1 Jun 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared at a later date upon request (e.g., the CRF to allow a collaborator to select the data they wish to access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the study investigator, based on a protocol provided by the requester, after verification of the obtaining of regulatory approvals, including the favorable opinion of an ethics committee.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude Des déterminants de l'évolution NEUrologique Des Patients Ayant présenté un Syndrome de Détresse Respiratoire aiguë
- ClinicalTrials.gov ID
- NCT07629973
- Acronym / sponsor ID
- NEURDS / 49RC25_0292
- Conditions
- Acute Respiratory Distress Syndrome (ARDS), s100b, Mechanical Power, Ventilator Induced Lung Injury, Transpulmonary Pressure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 17 Oct 2026 (estimated)
- Primary completion
- 23 Oct 2028 (estimated)
- Study completion
- 23 Oct 2029 (estimated)
- First posted
- 5 Jun 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.
Acute respiratory distress syndrome (ARDS) is characterized by pathological pulmonary edema caused by direct or indirect damage to the alveolar-capillary membrane.
Its management relies on etiological treatment, invasive mechanical ventilation, and the use of sedatives and neuromuscular blockers, depending on the patient's condition.
Improvements in patient care have led to an improved prognosis. However, in-hospital mortality remains high (between 35% and 45%). Notably, morbidity among surviving patients is very high and is largely dominated by neuropsychological sequelae. Attention and executive function disorders, confusion, disorientation, or memory impairment are thus found in 70 to 100% of patients following ARDS. These disorders are still present in 46 to 80% of surviving patients one year after ARDS and in 20% of them five years later.
Although essential to treatment, mechanical ventilation carries a risk of significant complications. Beyond the risk of infection and complications related to sedation and neuromuscular blockade, the use of mechanical ventilation is associated with a risk of ventilator-induced lung injury (VILI).
The use of so-called protective ventilation reduces the risk of VILI and improves patient outcomes. However, analysis of relevant physiological parameters shows that the risk of VILI may still exist even when ventilator settings comply with recommendations and the concept of protective ventilation. Driving pressure (which represents Strain) is a good marker of VILI; it represents the distension of the lung with each breath relative to the initial lung volume. Values above 14 cmH₂O are associated with high mortality in patients with ARDS. Inspiratory transpulmonary pressure represents Stress-that is, the pressure that distends the alveoli at the end of inspiration-and is also associated with the risk of VILI. Finally, mechanical power represents the amount of energy delivered to the lung by the ventilator and has been validated as a marker of VILI. The advantage of mechanical power over the other indices described is that it incorporates all components that can lead to VILI.
Among the various sources of neurological damage during ARDS, inflammatory processes appear to play a major role. Numerous inflammatory mediators (TNF-α, IL-6, IL-8, IL-1β) are secreted during ARDS, and animal studies have demonstrated a link between inflammation and hippocampal damage. Furthermore, cerebral ischemic lesions, exacerbated by systemic inflammation and endothelial activation leading to coagulation activation with thrombus formation, may also contribute to the development of cognitive impairments.
In addition to the inflammatory processes associated with ARDS, mechanical ventilation itself may have a significant impact on neuroinflammatory damage. Recently, the term "ventilator-associated brain injury" (VABI) has been proposed to describe these secondary neurological lesions induced by mechanical ventilation. Studies in mouse and pig models have demonstrated a relationship between the dose and duration of VILI, apoptosis, neuroinflammation, and neuronal damage. An animal study in mice also showed an association between the duration of mechanical ventilation and the onset of cognitive impairments.
During brain injury, proteins and neurotransmitters are released and serve as biomarkers of brain damage. Elevated plasma levels of S100B protein indicate astrocyte damage caused by traumatic, anoxic-ischemic, or inflammatory mechanisms. It correlates with neurological prognosis following cardiac arrest, in ischemic or hemorrhagic strokes, in neurodegenerative diseases, and in patients with traumatic brain injury.
Clinical studies have shown a negative correlation between elevated S100B protein levels, the MoCA (Montreal Cognitive Assessment) score, and the MMSE (Mini-mental state evaluation ) in patients with OSA (Obstructive Sleep Apnea) or COPD (chronic obstructive pulmonary disease), respectively, indicating an association between this protein and cognitive impairment.
The investigators therefore hypothesize that mechanical ventilation associated with high mechanical power is linked to a significant risk of brain injury, reflected by elevated serum S100B protein levels and the presence of neurocognitive disorders long after ARDS.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cohort | Experimental | Other: Blood test scores calculationscollection of oesophageal pressure data, mechanical power calculation, MOCA score collection and blood sample collection for S100B protein dosage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult patient
- Patient admitted to the intensive care unit less than 48 hours ago
- Patient diagnosed with mild, moderate or severe ARDS according to the Berlin classification based on the PaO₂/FiO₂ ratio, with a minimum PEEP set at 5 cmH₂O (16), of pulmonary aetiology:
- Patients fitted with an oesophageal pressure measurement catheter (Nutrivent, Sidam, San Giacomo Roncole, Italy)
- Patients registered with or covered by a social security scheme
Key exclusion criteria (9 listed)
- Patients with a history of central nervous system disorders resulting in cognitive impairment
- Patients on ECMO
- Patients admitted for symptomatic central nervous system disorders
- Patients admitted for acute respiratory distress syndrome following cardiorespiratory arrest.
- Patients being treated for a psychiatric condition, chronic heavy drinkers, or those undergoing long-term treatment with benzodiazepines, antidepressants or antipsychotics.
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 |
|---|---|---|
| Blood test scores calculationscollection of oesophageal pressure data, mechanical power calculation, MOCA score collection and blood sample collection for S100B protein dosage | Other | cohort |
Primary outcome
association between the mechanical power between Day 1 and Day 3 (reflecting the risk of VILI)
Time frame: at day 1, day 2 and day 3
mechanical power calculation
S-100B serum protein level between Day 1 (H0) and Day 3 (H72).
Time frame: at day 1, day 2 and day 3
S-100B protein dosage
9 secondary outcomes
association between serum S100B protein concentrations from day 1 to day 3 and neurological outcome at 3 months and 12 months
Time frame: at 3 and 12 months
association between other VILI markers (inspiratory transpulmonary pressure and driving pressure) and serum S100B protein concentrations from day 1 to day 3.
Time frame: From day 1 to day 3
association between these other VILI markers and neurological outcomes at 3 months and 12 months.
Time frame: at 3 and 12 months
association between the occurrence of delirium during a stay in the intensive care unit and neurological outcomes at 3 and 12 months.
Time frame: at 3 and 12 months
prevalence of depression among patients who presented ARDS
Time frame: at 3 months
prevalence of post-traumatic stress (PCL-5 score) among patients who presented ARDS
Time frame: at 3 months
prevalence of anxiety among patients who presented ARDS
Time frame: at 3 months
quality of life state (Euro 5d 5l score) among patients who presented ARDS
Time frame: at 3 months
prevalence of independence among patients who presented ARDS
Time frame: at 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 27 Jul 2026.
- Individual participant dataSharing planned: Yes. Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared at a later date upon request (e.g., the CRF to allow a collaborator to select the data they wish to access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the study investigator, based on a protocol provided by the requester, after verification of the obtaining of regulatory approvals, including the favorable opinion of an ethics committee.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Blood test scores calculations in people with Acute Respiratory Distress Syndrome (ARDS) and s100b, run by University Hospital, Angers.
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 9 inclusion and 9 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 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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 François Beloncle, Professor (+33 2 41 35 38 15, Francois.Beloncle@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
association between the mechanical power between Day 1 and Day 3 (reflecting the risk of VILI) (time frame: at day 1, day 2 and day 3). The study lists 2 primary outcomes in all. 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 27 Jul 2026.