Differential Clinical Phenotypes Of Early CD4+ And CD8+ T-Cell Recovery And Association With 28-Day Mortality In Sepsis Patients

Sichuan Provincial People's Hospital303 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

303

Conditions

Sepsis

Interventions

CD4+/CD8+ T-cell dynamic recovery statusOTHER

Dynamic recovery status of CD4⁺ and CD8⁺ T-lymphocyte subsets based on two sequential lymphocyte count measurements in sepsis patients, retrospective chart review, no investigator-initiated intervention.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (1)

Sichuan Provincial People's Hospital, Intensive Care Unit

Chengdu, Sichuan, China

Outcomes

Primary Outcomes

28-day all-cause mortality

All-cause mortality within 28 days after sepsis onset among adult ICU patients.

Time frame: Within 28 days of sepsis onset

Secondary Outcomes

Survival trajectories starting from T2 time-point

Compare post-T2 survival among four CD4⁺/CD8⁺ T-cell recovery phenotypes using Kaplan-Meier survival analysis (log-rank test). T2 is defined as the second sequential T-lymphocyte subset measurement.

Time frame: Within 25 days after T2 laboratory measurement

28-day all-cause mortality among patients with secondary infection occurring after T2

28-day all-cause mortality in the subgroup of patients with new-onset secondary infection strictly occurring after the T2 time-point.

Time frame: Within 28-days after the onset of secondary infection

Incremental discriminative performance of T-cell dynamic recovery for predicting 28-day mortality

Evaluate the incremental prognostic value of CD4⁺/CD8⁺ T-cell dynamic recovery for 28-day mortality by receiver-operating characteristic curve (AUC-ROC).

Time frame: At 28-day follow-up after enrollment

Data from ClinicalTrials.gov

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