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NCT Number: NCT07760415

EEG Changes and Cognitive 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.

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Key information

Conditions

Sepsis Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Infections Inflammation Mental Disorders Nervous System Diseases Neurocognitive Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Associated Encephalopathy Sepsis and Septic Shock Sepsis at Intensive Care Unit Sepsis-Associated Encephalopathy Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Xiangya Hospital of Central South University

Changsha, Hunan, 410008, China

Location contact

Lina Zhang, Dr.

CONTACT

[email protected]

86+15874875763

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

EEG monitoring

Device

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

Primary outcomes

  1. 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).

  2. 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.

Secondary outcomes

  1. 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.

    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.

  2. Mortality

    Time frame: Day 30, Day 90, and Day 180 post-enrollment.

    All-cause mortality collected through electronic medical records and structured telephone follow-up.

  3. Length of ICU Stay

    Time frame: Up to 180 days post-enrollment.

    Total duration of stay in the Intensive Care Unit in days.

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

    Time frame: Day 30, Day 90, and Day 180 post-enrollment.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lina Zhang, Dr.

CONTACT

[email protected]

86+15874875763

Sponsors and collaborators

Lead sponsor

Xiangya Hospital of Central South University

Other

Registry information

Official study title

Electroencephalogram Changes and Cognitive Function Profiles in Sepsis Patients With Different Inflammatory Phenotypes

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Aug 12, 2026
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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