Sepsis
Conditions
Keywords
Sepsis, Retrospective cohort, Clinical phenotype, Prognosis
Brief summary
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.
Detailed description
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.
Interventions
OTHERCD4+/CD8+ T-cell dynamic recovery status
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.
Sponsors
Sichuan Provincial People's Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 28-day all-cause mortality | Within 28 days of sepsis onset | All-cause mortality within 28 days after sepsis onset among adult ICU patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival trajectories starting from T2 time-point | Within 25 days after T2 laboratory measurement | 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. |
| 28-day all-cause mortality among patients with secondary infection occurring after T2 | Within 28-days after the onset of secondary infection | 28-day all-cause mortality in the subgroup of patients with new-onset secondary infection strictly occurring after the T2 time-point. |
| Incremental discriminative performance of T-cell dynamic recovery for predicting 28-day mortality | At 28-day follow-up after enrollment | Evaluate the incremental prognostic value of CD4⁺/CD8⁺ T-cell dynamic recovery for 28-day mortality by receiver-operating characteristic curve (AUC-ROC). |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORLin Chen, MD
Sichuan Provincial People's Hospital
Outcome results
None listed