NCT07760415

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for all trials

Timeline
9mo left

Started Aug 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Aug 2026May 2027

First Submitted

Initial submission to the registry

July 27, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 12, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

August 12, 2026

Status Verified

August 1, 2026

Enrollment Period

4 months

First QC Date

July 27, 2026

Last Update Submit

August 8, 2026

Conditions

SepsisSepsis Associated EncephalopathySepsis and Septic ShockSepsis at Intensive Care Unit

Keywords

SepsisSepsis-Associated EncephalopathyElectroencephalogramInflammatory PhenotypeCognitive Dysfunction

Outcome Measures

Primary Outcomes (2)

  • 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).

    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.

    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

    Baseline (Day 1), Day 2, Day 3, Day 7, Day 30, Day 90, and Day 180 post-enrollment.

  • Mortality

    Day 30, Day 90, and Day 180 post-enrollment.

  • Length of ICU Stay

    Up to 180 days post-enrollment.

  • Health-Related Quality of Life (EQ-5D-5L Index)

    Day 30, Day 90, and Day 180 post-enrollment.

Study Arms (2)

High Inflammatory Phenotype Group

Septic patients displaying serum Interleukin-6 (IL-6) ≥ 400 pg/mL upon ICU admission (Day 1) .

Device: EEG monitoring

Low Inflammatory Phenotype Group

Septic patients displaying serum Interleukin-6 (IL-6) \< 400 pg/mL upon ICU admission (Day 1) .

Device: EEG monitoring

Interventions

EEG monitoringDEVICE

Standard sepsis bundle treatment + 72-hour quantitative continuous EEG monitoring + structured long-term cognitive follow-up.

High Inflammatory Phenotype GroupLow Inflammatory Phenotype Group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiangya Hospital of Central South University

Changsha, Hunan, 410008, China

Location

Related Publications (6)

  • 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.

    PMID: 39014421BACKGROUND

  • Shankar-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 Jun 16. doi: 10.1007/s00134-026-08489-0. Online ahead of print.

    PMID: 42301312BACKGROUND

  • Young 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.

    PMID: 1552002BACKGROUND

  • Oddo 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.

    PMID: 19384197BACKGROUND

  • Faix JD. Biomarkers of sepsis. Crit Rev Clin Lab Sci. 2013 Jan-Feb;50(1):23-36. doi: 10.3109/10408363.2013.764490.

    PMID: 23480440BACKGROUND

  • Gofton 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.

    PMID: 22986430BACKGROUND

MeSH Terms

Conditions

SepsisSepsis-Associated EncephalopathyShock, SepticCognitive Dysfunction

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesShockCognition DisordersNeurocognitive DisordersMental Disorders

Central Study Contacts

Lina Zhang, Dr.

CONTACT

86+15874875763zln7095@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chief of the Department of Critical Care Medicine

Study Record Dates

First Submitted

July 27, 2026

First Posted

August 12, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

December 12, 2026

Study Completion (Estimated)

May 1, 2027

Last Updated

August 12, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)