Differential Clinical Phenotypes Of Early CD4+ And CD8+ T-Cell Dynamic Recovery And Their Association With 28-Day All-Cause Mortality Among Sepsis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 303
- 主要终点
- 28-day all-cause mortality
研究概览
简要总结
This is a retrospective non-interventional cohort study. Medical records of adult patients with sepsis admitted to the intensive care unit will be retrospectively reviewed. We aim to compare clinical manifestations, laboratory indicators and prognosis among different sepsis phenotypes, so as to provide clinical reference for early identification and risk stratification of sepsis. No intervention will be performed on patients in this study.
详细描述
Sepsis is a life-threatening organ dysfunction caused by dysregulated host response to infection. Heterogeneity exists among sepsis patients, and different phenotypes present distinct clinical features and prognostic outcomes. This single-center retrospective cohort study will enroll adult sepsis patients from Sichuan Provincial People's Hospital. Clinical data including demographic characteristics, infection source, vital signs, laboratory examinations, treatment information and survival outcomes will be extracted from electronic medical records. Patients will be grouped according to sepsis subtypes, and clinical features among groups will be analyzed and compared. Only existing historical medical record data will be used; no additional examinations or interventions will be imposed on subjects. The study has been approved by the hospital ethics committee.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old
- •Diagnosis of sepsis according to Sepsis-3.0 criteria (infection plus SOFA score ≥2), admitted to intensive care unit
- •At least two sequential peripheral blood CD4⁺ and CD8⁺ T-cell absolute count measurements (T1 and T2) during ICU stay
- •Interval between T1 and T2 > 3 days
排除标准
- •Age < 18 years old
- •Death within 24 hours after ICU admission
- •Lack of baseline T-lymphocyte subset testing within 72 hours of ICU admission
- •Receiving glucocorticoid or other immunosuppressive therapy at enrollment
- •Pregnancy or puerperium status
- •Critical clinical data missing for analysis
结局指标
主要结局
28-day all-cause mortality
时间窗: Within 28 days of sepsis onset
All-cause mortality within 28 days after sepsis onset among adult ICU patients.
次要结局
- Survival trajectories starting from T2 time-point(Within 25 days after T2 laboratory measurement)
- 28-day all-cause mortality among patients with secondary infection occurring after T2(Within 28-days after the onset of secondary infection)
- Incremental discriminative performance of T-cell dynamic recovery for predicting 28-day mortality(At 28-day follow-up after enrollment)
研究者
Lin Chen
Chief Physician, Department of Respiratory and Critical Care Medicine, Sichuan Provincial People's Hospital
Sichuan Provincial People's Hospital