Sepsis, Sepsis and Septic Shock, Sepsis Associated Encephalopathy, Sepsis at Intensive Care Unit
Conditions
Keywords
Sepsis, Sepsis-Associated Encephalopathy, Electroencephalogram, Inflammatory Phenotype, Cognitive Dysfunction
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.
Interventions
DEVICEEEG monitoring
Standard sepsis bundle treatment + 72-hour quantitative continuous EEG monitoring + structured long-term cognitive follow-up.
Sponsors
Xiangya Hospital of Central South University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quantified EEG Features and Young Classification Grade | 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). |
| Favorable Neurological Prognosis Rate (CPC Score) | 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
| Measure | Time frame | Description |
|---|---|---|
| Montreal Cognitive Assessment (MoCA) Score | 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. |
| Mortality | Day 30, Day 90, and Day 180 post-enrollment. | All-cause mortality collected through electronic medical records and structured telephone follow-up. |
| Length of ICU Stay | Up to 180 days post-enrollment. | Total duration of stay in the Intensive Care Unit in days. |
| Health-Related Quality of Life (EQ-5D-5L Index) | 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. |
Countries
China
Contacts
CONTACTLina Zhang, Dr.
Outcome results
None listed