Electroencephalogram Changes and Cognitive Function Profiles in Sepsis Patients With Different Inflammatory Phenotypes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Quantified EEG Features and Young Classification Grade
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
High Inflammatory Phenotype Group
Septic patients displaying serum Interleukin-6 (IL-6) ≥ 400 pg/mL upon ICU admission (Day 1) .
干预措施: EEG monitoring (Device)
Low Inflammatory Phenotype Group
Septic patients displaying serum Interleukin-6 (IL-6) < 400 pg/mL upon ICU admission (Day 1) .
干预措施: EEG monitoring (Device)
结局指标
主要结局
Quantified EEG Features and Young Classification Grade
时间窗: 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)
时间窗: 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.
次要结局
- Montreal Cognitive Assessment (MoCA) Score(Baseline (Day 1), Day 2, Day 3, Day 7, Day 30, Day 90, and Day 180 post-enrollment.)
- Mortality(Day 30, Day 90, and Day 180 post-enrollment.)
- Length of ICU Stay(Up to 180 days post-enrollment.)
- Health-Related Quality of Life (EQ-5D-5L Index)(Day 30, Day 90, and Day 180 post-enrollment.)
研究者
Lina Zhang, MD, PhD
Professor and Chief of the Department of Critical Care Medicine
Xiangya Hospital of Central South University