Sepsis Associated Encephalopathy / Sepsis and Septic Shock / EEG monitoring · Observational Study

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

ClinicalTrials.gov · August 12, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a prospective observational study registered but not yet recruiting, designed to characterize EEG patterns and cognitive outcomes across inflammatory phenotypes of sepsis patients over 6 months. No results are available; the study is in planning phase only.

What was studied

Observational. Sepsis, Sepsis Associated Encephalopathy, Sepsis and Septic Shock, Sepsis at Intensive Care Unit; age from 18 Years; to 90 Years. Intervention: High Inflammatory Phenotype Group; Low Inflammatory Phenotype Group. n = 78. 1 site: China.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

Once results are published, this study may provide insight into EEG markers of neurological complications in sepsis and their relationship to long-term cognitive outcomes, potentially informing monitoring strategies. At present, no clinical guidance can be drawn from a registry record.

Plain-language summary

This is a registry record for a planned observational study with no results posted; enrollment has not yet begun, making it an early-phase descriptive design that cannot yet support clinical conclusions.

Study design

As stated by the source record.

MethodsCohort model. Prospective time perspective. Primary outcome measures: Quantified EEG Features and Young Classification Grade (assessed at 72 hours after enrollment); Favorable Neurological Prognosis Rate (CPC Score) (assessed at Baseline (Day 1), Day 2, Day 3, Day 7, Day 30, Day 90, and Day 180 post-enrollm…)

DesignObservational

PopulationSepsis, Sepsis Associated Encephalopathy, Sepsis and Septic Shock, Sepsis at Intensive Care Unit; age from 18 Years; to 90 Years

Sample size78

InterventionHigh Inflammatory Phenotype Group; Low Inflammatory Phenotype Group

Setting1 site: China

Reported figures

Quoted from the source exactly as published.

Planned sample size78

Primary outcome 1Quantified EEG Features and Young Classification Grade at 72 hours

Primary outcome 2Favorable Neurological Prognosis Rate (CPC Score) at Baseline, Days 2, 3, 7, 30, 90, and 180

Clinical bottom line

Caveats

No results reported; study has not yet begun recruitment.
No sample size justification, power calculation, or per-group allocation provided.
No analytical plan, blinding, or bias mitigation strategies described in registry record.
Observational design without comparison group limits ability to establish causation or effect magnitude.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

limited

Observational design without control group or randomization limits causal inference.

Directness

moderate

EEG and cognitive outcomes directly address sepsis-associated encephalopathy, relevant to clinical practice.

Consistency

insufficient

Single planned study; no prior results or comparisons available in registry record.

Risk of bias

insufficient

No methods, blinding, or analytical protocol described in registry record.

Sample adequacy

limited

Estimated 78 participants total; no power calculation or per-group breakdown stated.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07760415). This is a study registration, not published results. Lead sponsor: Xiangya Hospital of Central South University. Recruitment status: NOT_YET_RECRUITING. Study type: OBSERVATIONAL. Enrollment: 78 participants (ESTIMATED). Conditions: Sepsis, Sepsis Associated Encephalopathy, Sepsis and Septic Shock, Sepsis at Intensive Care Unit. Interventions: DEVICE: EEG monitoring. Primary outcome measures: Quantified EEG Features and Young Classification Grade , 72 hours after enrollment; Favorable Neurological Prognosis Rate (CPC Score) , Baseline (Day 1), Day 2, Day 3, Day 7, Day 30, Day 90, and Day 180 post-enrollment.. 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Sepsis Associated EncephalopathySepsis and Septic ShockNCT07760415EEG monitoringXiangya Hospital of Central South UniversitySepsis