EEG Changes and Cognitive Profiles in Sepsis Patients With Different Inflammatory Phenotypes

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorXiangya Hospital of Central South University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • EEG monitoring

    Device

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

Treatment groups

78 Participants
are divided into 2 treatment groups
Group A: High Inflammatory Phenotype Group1 intervention
Group B: Low Inflammatory Phenotype Group1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
72 hours after enrollment
2

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.

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

Secondary outcomes

1

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.

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

Mortality

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

Time frame
Day 30, Day 90, and Day 180 post-enrollment.
3

Length of ICU Stay

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

Time frame
Up to 180 days post-enrollment.
4

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.

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

Other outcomes

Sponsors and contacts

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