About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Pregnancy or lactation
Cardiopulmonary-cerebral resuscitation (CPCR) performed during the current hospital admission
Trial 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
EEG monitoring
DeviceStandard sepsis bundle treatment + 72-hour quantitative continuous EEG monitoring + structured long-term cognitive follow-up.
Treatment groups
Trial outcomes
Primary outcomes
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).
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.
Secondary outcomes
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.
Mortality
All-cause mortality collected through electronic medical records and structured telephone follow-up.
Length of ICU Stay
Total duration of stay in the Intensive Care Unit in days.
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.
Sponsors and contacts
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