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

NCT07787780 | Completed

• 1 other identifier: LunShen-Yan-2024-No396
• Study Type: observational
• Target: 303
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis

Keywords

Sepsis; Retrospective cohort; Clinical phenotype; Prognosis

Outcome Measures

Primary Outcomes (1)

• 28-day all-cause mortality

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

  Within 28 days of sepsis onset

Secondary Outcomes (3)

• 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

Study Arms (4)

CD4 and CD8 non-recovery cohort

Sepsis patients with neither CD4⁺ nor CD8⁺ T-cell recovery. Retrospective chart review, no study-specific intervention.

Other: CD4+/CD8+ T-cell dynamic recovery status

CD8-only recovery cohort

Sepsis patients with only CD8⁺ T-cell recovery. Retrospective chart review, no study-specific intervention.

Other: CD4+/CD8+ T-cell dynamic recovery status

CD4-only recovery cohort

Sepsis patients with only CD4⁺ T-cell recovery. Retrospective chart review, no study-specific intervention.

Other: CD4+/CD8+ T-cell dynamic recovery status

Dual CD4 and CD8 recovery cohort

Sepsis patients with both CD4⁺ and CD8⁺ T-cell recovery. Retrospective chart review, no study-specific intervention。

Other: CD4+/CD8+ T-cell dynamic recovery status

Interventions

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.

CD4 and CD8 non-recovery cohort; CD4-only recovery cohort; CD8-only recovery cohort; Dual CD4 and CD8 recovery cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult ICU patients with sepsis meeting Sepsis-3.0 criteria, who had at least two serial CD4⁺/CD8⁺ T-lymphocyte subset tests during ICU hospitalization. Retrospective observational cohort from single-center ICU database.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sichuan Provincial People's Hospital: lead

Study Sites (1)

Sichuan Provincial People's Hospital, Intensive Care Unit

Chengdu, Sichuan, 610072, China

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

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

Study Officials

• Lin Chen, MD

  Sichuan Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Department of Respiratory and Critical Care Medicine, Sichuan Provincial People's Hospital

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 26, 2026
• Study Start: January 1, 2022
• Primary Completion: January 28, 2025
• Study Completion: April 1, 2025
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)