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NCT Number: NCT07787780

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

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.

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sichuan Provincial People's Hospital, Intensive Care Unit

Chengdu, Sichuan, 610072, China

About 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CD4+/CD8+ T-cell dynamic recovery status

Other

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.

Primary outcomes

  1. 28-day all-cause mortality

    Time frame: Within 28 days of sepsis onset

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

Secondary outcomes

  1. Survival trajectories starting from T2 time-point

    Time frame: 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.

  2. 28-day all-cause mortality among patients with secondary infection occurring after T2

    Time frame: 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.

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

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Sichuan Provincial People's Hospital

Other

Registry information

Official study title

Differential Clinical Phenotypes Of Early CD4+ And CD8+ T-Cell Dynamic Recovery And Their Association With 28-Day All-Cause Mortality Among Sepsis Patients

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 26, 2026
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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