SepsisNCT07787780
Differential Clinical Phenotypes Of Early CD4+ And CD8+ T-Cell Recovery And Association With 28-Day Mortality In Sepsis Patients
An observational study of Sepsis, run by Sichuan Provincial People's Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- CD4+/CD8+ T-cell dynamic recovery status
- How many people
- 303 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 1 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Sichuan Provincial People's Hospital, Intensive Care Unit
Chengdu, Sichuan, 610072
About this study
Official 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
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.
Read the 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.
- Conditions
- Sepsis
- Being tested
- CD4+/CD8+ T-cell dynamic recovery status
- Keywords
- Sepsis, Retrospective cohort, Clinical phenotype, Prognosis
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| CD4 and CD8 non-recovery cohort | Sepsis patients with neither CD4⁺ nor CD8⁺ T-cell recovery. Retrospective chart review, no study-specific intervention. Receives: 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. Receives: 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. Receives: 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。 Receives: Other: CD4+/CD8+ T-cell dynamic recovery status |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day all-cause mortality
All-cause mortality within 28 days after sepsis onset among adult ICU patients.
Measured: Within 28 days of sepsis onset
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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).
Measured: At 28-day follow-up after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start1 Jan 2022
- Primary completion28 Jan 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sichuan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Chen, Sichuan Provincial People's Hospital
- Investigators
- Lin Chen, MD, Principal investigator, Sichuan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07787780
- Sponsor's protocol ID
- LunShen-Yan-2024-No396
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual-level patient data will not be shared due to patient privacy and local hospital data management regulations.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07787780
- Acronym / sponsor ID
- LunShen-Yan-2024-No396
- Conditions
- Sepsis
- Keywords
- Sepsis, Retrospective cohort, Clinical phenotype, Prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- Sichuan Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 28 Jan 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CD4 and CD8 non-recovery cohort | – | Other: CD4+/CD8+ T-cell dynamic recovery statusSepsis patients with neither CD4⁺ nor CD8⁺ T-cell recovery. Retrospective chart review, no study-specific intervention. |
| CD8-only recovery cohort | – | Other: CD4+/CD8+ T-cell dynamic recovery statusSepsis patients with only CD8⁺ T-cell recovery. Retrospective chart review, no study-specific intervention. |
| CD4-only recovery cohort | – | Other: CD4+/CD8+ T-cell dynamic recovery statusSepsis patients with only CD4⁺ T-cell recovery. Retrospective chart review, no study-specific intervention. |
| Dual CD4 and CD8 recovery cohort | – | Other: CD4+/CD8+ T-cell dynamic recovery statusSepsis patients with both CD4⁺ and CD8⁺ T-cell recovery. Retrospective chart review, no study-specific intervention。 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CD4+/CD8+ T-cell dynamic recovery statusDynamic 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. | Other | CD4 and CD8 non-recovery cohort, CD4-only recovery cohort, CD8-only recovery cohort, Dual CD4 and CD8 recovery cohort |
Primary outcome
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.
3 secondary outcomes
Survival trajectories starting from T2 time-point
Time frame: Within 25 days after T2 laboratory measurement
28-day all-cause mortality among patients with secondary infection occurring after T2
Time frame: Within 28-days after the onset of secondary infection
Incremental discriminative performance of T-cell dynamic recovery for predicting 28-day mortality
Time frame: At 28-day follow-up after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No. Individual-level patient data will not be shared due to patient privacy and local hospital data management regulations.
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
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CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
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Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lin Chen, MD principal investigator
Sichuan Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Sichuan Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day all-cause mortality (time frame: Within 28 days of sepsis onset). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.