SepsisNCT07760415
EEG Changes and Cognitive Profiles in Sepsis Patients With Different Inflammatory Phenotypes
An observational study of Sepsis and Sepsis Associated Encephalopathy, run by Xiangya Hospital of Central South University at 1 site in China.
Trial summary
To characterize the electroencephalogram (EEG) features of sepsis patients with distinct inflammatory response phenotypes, dynamically track their evolutionary trajectories, and analyze their associations with long-term changes in cognitive function. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Sepsis, Sepsis Associated Encephalopathy, Sepsis and Septic Shock
- What is being tested?
- EEG monitoring
- Type of treatment
- Medical device
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2026to 1 May 2027
- Phase
- Observational
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult sepsis patients admitted to ICU at Xiangya Hospital, diagnosed according to Sepsis-3.0 criteria, with expected survival ≥24 hours. Patients with primary CNS diseases, post-CPCR status, pregnancy/lactation, or contraindications to EEG monitoring will be excluded.
Who may be able to join
- Age ≥18 years and ≤90 years
- First-time admission to the Intensive Care Unit (ICU)
- Diagnosis of sepsis according to Sepsis-3.0 criteria (documented or clinically suspected infection plus Sequential Organ Failure Assessment [SOFA] score ≥2 points)
- Expected ICU survival time ≥24 hours
- Written informed consent provided by the patient or legal surrogate
Who cannot join
- Pregnancy or lactation
- Cardiopulmonary-cerebral resuscitation (CPCR) performed during the current hospital admission
- Pre-existing primary central nervous system (CNS) diseases, including:
- Acute cerebrovascular disease (e.g., hemiplegia, cranial nerve palsy) Central nervous system infection (e.g., pleocytosis in cerebrospinal fluid) Organic or metabolic encephalopathy (e.g., hepatic, renal, pulmonary, pancreatic, or severe inherited metabolic disorders) Drug-related encephalopathy (e.g., antipsychotic-associated encephalopathy, serotonin syndrome, neurotoxic antibiotics) Other structural or immunological brain diseases (e.g., traumatic brain injury, intracranial neoplasm, autoimmune encephalopathy)
- Inability to cooperate with or tolerate scalp EEG electrode placement (e.g., extensive scalp trauma or open scalp infection)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Xiangya Hospital of Central South University
Changsha, Hunan, 410008
Lina Zhang, Dr., 86+15874875763, zln7095@163.com
About this study
Official title: Electroencephalogram Changes and Cognitive Function Profiles in Sepsis Patients With Different Inflammatory Phenotypes
To characterize the electroencephalogram (EEG) features of sepsis patients with distinct inflammatory response phenotypes, dynamically track their evolutionary trajectories, and analyze their associations with long-term changes in cognitive function.
- Conditions
- Sepsis, Sepsis Associated Encephalopathy, Sepsis and Septic Shock, Sepsis at Intensive Care Unit
- Being tested
- EEG monitoring
- Keywords
- Sepsis, Sepsis-Associated Encephalopathy, Electroencephalogram, Inflammatory Phenotype, Cognitive Dysfunction
- Medical subject headings
- Sepsis, Sepsis-Associated Encephalopathy, Shock, Septic, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG monitoringDevice
Standard sepsis bundle treatment + 72-hour quantitative continuous EEG monitoring + structured long-term cognitive follow-up.
| Study group | Role | What they receive |
|---|---|---|
| High Inflammatory Phenotype Group | Septic patients displaying serum Interleukin-6 (IL-6) ≥ 400 pg/mL upon ICU admission (Day 1) . Receives: Device: EEG monitoring | |
| Low Inflammatory Phenotype Group | Septic patients displaying serum Interleukin-6 (IL-6) < 400 pg/mL upon ICU admission (Day 1) . Receives: Device: EEG monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantified EEG Features and Young Classification Grade
Description: Power spectral density (delta, theta, alpha, beta frequency bands), relative delta band power ratio (1-4 Hz), epileptiform discharge frequency, burst-suppression ratio, and Young EEG grading (Grade I to VI, double-blinded expert consensus reading).
Measured: 72 hours after enrollment
Favorable Neurological Prognosis Rate (CPC Score)
Neurological outcome assessed using the Cerebral Performance Category (CPC) scale. The CPC score ranges from 1 to 5, with lower scores indicating better neurological function. CPC scores of 1-2 indicate favorable neurological outcomes, whereas CPC scores of 3-5 indicate unfavorable neurological outcomes.
Measured: Baseline (Day 1), Day 2, Day 3, Day 7, Day 30, Day 90, and Day 180 post-enrollment.
Secondary outcomes (4)
Montreal Cognitive Assessment (MoCA) Score
Cognitive function assessed using the Montreal Cognitive Assessment (MoCA) scale. The total MoCA score ranges from 0 to 30, with higher scores indicating better cognitive function. A MoCA score <26 is defined as cognitive impairment.
Measured: Baseline (Day 1), Day 2, Day 3, Day 7, Day 30, Day 90, and Day 180 post-enrollment.
Mortality
All-cause mortality collected through electronic medical records and structured telephone follow-up.
Measured: Day 30, Day 90, and Day 180 post-enrollment.
Length of ICU Stay
Total duration of stay in the Intensive Care Unit in days.
Measured: Up to 180 days post-enrollment.
Health-Related Quality of Life (EQ-5D-5L Index)
Health-related quality of life assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index. The EQ-5D-5L index score ranges from -0.594 to 1.000, with higher scores indicating better health-related quality of life.
Measured: Day 30, Day 90, and Day 180 post-enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completion12 Dec 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lina Zhang, MD, PhD, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07760415
- Sponsor's protocol ID
- 2025122202
- Other IDs
- 2025122202
- Status last verified
- Aug 2026
- First submitted
- 27 Jul 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bitar R, Khan UM, Rosenthal ES. Utility and rationale for continuous EEG monitoring: a primer for the general intensivist. Crit Care. 2024 Jul 16;28(1):244. doi: 10.1186/s13054-024-04986-0.
PubMed 39014421Shankar-Hari M, Benghanem S, Bourhy L, Cunningham C, Ehler J, Girard TD, Gofton TE, Hermann B, Jiwaji Z, Mazeraud A, Needham E, Rosa RG, Singer M, Slooter AJC, Sonneville R, Stevens RD, Taccone FS, Sharshar T. Current knowledge and challenges of sepsis-associated encephalopathy. Intensive Care Med. 2026 Aug;52(8):1679-1696. doi: 10.1007/s00134-026-08489-0. Epub 2026 Jun 16.
PubMed 42301312Young GB, Bolton CF, Archibald YM, Austin TW, Wells GA. The electroencephalogram in sepsis-associated encephalopathy. J Clin Neurophysiol. 1992 Jan;9(1):145-52. doi: 10.1097/00004691-199201000-00016.
PubMed 1552002Oddo M, Carrera E, Claassen J, Mayer SA, Hirsch LJ. Continuous electroencephalography in the medical intensive care unit. Crit Care Med. 2009 Jun;37(6):2051-6. doi: 10.1097/CCM.0b013e3181a00604.
PubMed 19384197Faix JD. Biomarkers of sepsis. Crit Rev Clin Lab Sci. 2013 Jan-Feb;50(1):23-36. doi: 10.3109/10408363.2013.764490.
PubMed 23480440Gofton TE, Young GB. Sepsis-associated encephalopathy. Nat Rev Neurol. 2012 Oct;8(10):557-66. doi: 10.1038/nrneurol.2012.183. Epub 2012 Sep 18.
PubMed 22986430
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroencephalogram Changes and Cognitive Function Profiles in Sepsis Patients With Different Inflammatory Phenotypes
- ClinicalTrials.gov ID
- NCT07760415
- Acronym / sponsor ID
- 2025122202
- Conditions
- Sepsis, Sepsis Associated Encephalopathy, Sepsis and Septic Shock, Sepsis at Intensive Care Unit
- Keywords
- Sepsis, Sepsis-Associated Encephalopathy, Electroencephalogram, Inflammatory Phenotype, Cognitive Dysfunction
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 12 Dec 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 12 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 characterize the electroencephalogram (EEG) features of sepsis patients with distinct inflammatory response phenotypes, dynamically track their evolutionary trajectories, and analyze their associations with long-term changes in cognitive function.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Inflammatory Phenotype Group | – | Device: EEG monitoringSeptic patients displaying serum Interleukin-6 (IL-6) ≥ 400 pg/mL upon ICU admission (Day 1) . |
| Low Inflammatory Phenotype Group | – | Device: EEG monitoringSeptic patients displaying serum Interleukin-6 (IL-6) < 400 pg/mL upon ICU admission (Day 1) . |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult sepsis patients admitted to ICU at Xiangya Hospital, diagnosed according to Sepsis-3.0 criteria, with expected survival ≥24 hours. Patients with primary CNS diseases, post-CPCR status, pregnancy/lactation, or contraindications to EEG monitoring will be excluded.
Key inclusion criteria (5 listed)
- Age ≥18 years and ≤90 years
- First-time admission to the Intensive Care Unit (ICU)
- Diagnosis of sepsis according to Sepsis-3.0 criteria (documented or clinically suspected infection plus Sequential Organ Failure Assessment [SOFA] score ≥2 points)
- Expected ICU survival time ≥24 hours
- Written informed consent provided by the patient or legal surrogate
Key exclusion criteria (5 listed)
- Pregnancy or lactation
- Cardiopulmonary-cerebral resuscitation (CPCR) performed during the current hospital admission
- Pre-existing primary central nervous system (CNS) diseases, including:
- Acute cerebrovascular disease (e.g., hemiplegia, cranial nerve palsy) Central nervous system infection (e.g., pleocytosis in cerebrospinal fluid) Organic or metabolic encephalopathy (e.g., hepatic, renal, pulmonary, pancreatic, or severe inherited metabolic disorders) Drug-related encephalopathy (e.g., antipsychotic-associated encephalopathy, serotonin syndrome, neurotoxic antibiotics) Other structural or immunological brain diseases (e.g., traumatic brain injury, intracranial neoplasm, autoimmune encephalopathy)
- Inability to cooperate with or tolerate scalp EEG electrode placement (e.g., extensive scalp trauma or open scalp infection)
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 |
|---|---|---|
| EEG monitoringStandard sepsis bundle treatment + 72-hour quantitative continuous EEG monitoring + structured long-term cognitive follow-up. | Device | High Inflammatory Phenotype Group, Low Inflammatory Phenotype Group |
Primary outcome
Quantified EEG Features and Young Classification Grade
Time frame: 72 hours after enrollment
Description: Power spectral density (delta, theta, alpha, beta frequency bands), relative delta band power ratio (1-4 Hz), epileptiform discharge frequency, burst-suppression ratio, and Young EEG grading (Grade I to VI, double-blinded expert consensus reading).
Favorable Neurological Prognosis Rate (CPC Score)
Time frame: Baseline (Day 1), Day 2, Day 3, Day 7, Day 30, Day 90, and Day 180 post-enrollment.
Neurological outcome assessed using the Cerebral Performance Category (CPC) scale. The CPC score ranges from 1 to 5, with lower scores indicating better neurological function. CPC scores of 1-2 indicate favorable neurological outcomes, whereas CPC scores of 3-5 indicate unfavorable neurological outcomes.
4 secondary outcomes
Montreal Cognitive Assessment (MoCA) Score
Time frame: Baseline (Day 1), Day 2, Day 3, Day 7, Day 30, Day 90, and Day 180 post-enrollment.
Mortality
Time frame: Day 30, Day 90, and Day 180 post-enrollment.
Length of ICU Stay
Time frame: Up to 180 days post-enrollment.
Health-Related Quality of Life (EQ-5D-5L Index)
Time frame: Day 30, Day 90, and Day 180 post-enrollment.
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 12 Aug 2026.
- Background: PubMed 39014421Bitar R, Khan UM, Rosenthal ES. Utility and rationale for continuous EEG monitoring: a primer for the general intensivist. Crit Care. 2024 Jul 16;28(1):244. doi: 10.1186/s13054-024-04986-0.
- Background: PubMed 42301312Shankar-Hari M, Benghanem S, Bourhy L, Cunningham C, Ehler J, Girard TD, Gofton TE, Hermann B, Jiwaji Z, Mazeraud A, Needham E, Rosa RG, Singer M, Slooter AJC, Sonneville R, Stevens RD, Taccone FS, Sharshar T. Current knowledge and challenges of sepsis-associated encephalopathy. Intensive Care Med. 2026 Aug;52(8):1679-1696. doi: 10.1007/s00134-026-08489-0. Epub 2026 Jun 16.
- Background: PubMed 1552002Young GB, Bolton CF, Archibald YM, Austin TW, Wells GA. The electroencephalogram in sepsis-associated encephalopathy. J Clin Neurophysiol. 1992 Jan;9(1):145-52. doi: 10.1097/00004691-199201000-00016.
- Background: PubMed 19384197Oddo M, Carrera E, Claassen J, Mayer SA, Hirsch LJ. Continuous electroencephalography in the medical intensive care unit. Crit Care Med. 2009 Jun;37(6):2051-6. doi: 10.1097/CCM.0b013e3181a00604.
- Background: PubMed 23480440Faix JD. Biomarkers of sepsis. Crit Rev Clin Lab Sci. 2013 Jan-Feb;50(1):23-36. doi: 10.3109/10408363.2013.764490.
- Background: PubMed 22986430Gofton TE, Young GB. Sepsis-associated encephalopathy. Nat Rev Neurol. 2012 Oct;8(10):557-66. doi: 10.1038/nrneurol.2012.183. Epub 2012 Sep 18.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Sepsis Associated Encephalopathy, run by Xiangya Hospital of Central South University at 1 site in China.
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 5 inclusion and 5 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 12 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 China. 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 Lina Zhang, Dr. (86+15874875763, zln7095@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantified EEG Features and Young Classification Grade (time frame: 72 hours after enrollment). 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?
On the ClinicalTrials.gov record for NCT07760415, which also lists 6 linked publications.
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 12 Aug 2026.