SepsisNCT07680816
Metabolic and Functional Study of γδ T Cells in Critically Ill Patients
An observational study of Sepsis and Critical Illness, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
This prospective observational cohort study investigates the subset-specific metabolic adaptation and functional remodeling of cytotoxic γδ T cells in critically ill patients with and without sepsis. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sepsis, Critical Illness, Immunosuppression
- How many people
- 105 participants
- Where
- 1 siteChina
- Study dates
- 21 Jun 2026to 15 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population comprises three distinct groups: healthy volunteers, non-septic critically ill patients, and septic critically ill patients admitted to the intensive care unit. Sepsis is defined according to the Sepsis-3 criteria (infection with an acute increase in SOFA score ≥2 points), while critical illness is based on standard ICU admission criteria. All participants must be aged ≥18 years and provide written informed consent (from the participant or a legally authorized representative for those unable to consent). Key exclusion criteria include known immunodeficiency, recent use of T-cell-targeted immunosuppressants or immune checkpoint inhibitors, expected ICU stay <24 hours, pregnancy, active major bleeding, or inability to obtain consent. Consecutive enrollment will take place at the Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, with follow-up through 90 days after enrollment.
Who may be able to join
- Healthy Control Group (NHC):
- Age ≥ 18 years.
- No acute or chronic major diseases.
- Provide written informed consent.
- Non-septic Critical Illness Group (CI-NS):
- Age ≥ 18 years.
Show all 13Show fewer
- Admitted to the ICU and meeting the definition of critical illness.
- Excluded from sepsis according to the Sepsis-3 criteria (infection + ΔSOFA ≥ 2 points).
- Written informed consent provided by the participant or legally authorized representative.
- Septic Critical Illness Group (CI-Sep):
- Age ≥ 18 years.
- Admitted to the ICU and meeting the Sepsis-3 criteria (infection + ΔSOFA ≥ 2 points).
- Written informed consent provided by the participant or legally authorized representative.
Who cannot join
- Age < 18 years.
- Known immunodeficiency, HIV infection, active hematologic malignancy, or history of hematopoietic stem cell or solid organ transplantation within the past 3 months.
- Receipt of T-cell-targeted immunosuppressive therapy (e.g., antithymocyte globulin, calcineurin inhibitors, mycophenolate mofetil, methotrexate, or high-dose corticosteroids >1 mg/kg/day prednisone equivalent) before ICU admission or within 24 hours after ICU admission.
- Use of immune checkpoint inhibitors (e.g., anti-PD-1/PD-L1/CTLA-4 antibodies) within the past 6 weeks.
- Expected ICU stay < 24 hours or imminent risk of death (moribund state).
- Pregnancy or breastfeeding.
- Active major bleeding.
- Inability to obtain informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Outside of the US, 430022
Jiancheng Zhang, Dr., 13554105815, zhjcheng1@126.com
About this study
Official title: Subset-specific Metabolic Adaptation and Functional Remodeling of Gamma Delta T (γδ T) Cells in Critically Ill ICU Patients: A Single-center, Prospective, Observational Cohort Study.
This prospective observational cohort study investigates the subset-specific metabolic adaptation and functional remodeling of cytotoxic γδ T cells in critically ill patients with and without sepsis. As a bridge between innate and adaptive immunity, γδ T cells contribute to early antimicrobial defense; however, their cytotoxic function and its metabolic regulation in sepsis remain incompletely understood. Our preliminary single-cell transcriptomic analysis revealed altered expression of cytotoxicity-associated genes (GZMB, PRF1, and GNLY) and mitochondrial oxidative phosphorylation (OXPHOS) pathway genes in cytotoxic γδ T cells from patients with sepsis. In particular, COX6C expression correlated with cytotoxic effector gene expression. Across healthy volunteers, critically ill non-septic patients, and critically ill septic patients, we will integrate flow cytometry, mitochondrial function assays, and functional validation experiments to characterize circulating cytotoxic γδ T-cell abundance and function and examine the contribution of COX6C to mitochondrial dysfunction and impaired cytotoxicity.
To investigate the relationship between systemic tryptophan metabolism and these cellular abnormalities, targeted tryptophan-pathway metabolomics using liquid chromatography-tandem mass spectrometry (LC-MS/MS) will quantify kynurenic acid (KYNA), tryptophan, kynurenine, and related metabolites in paired peripheral blood and fecal samples. Patients with sepsis will be stratified into older (≥65 years) and non-older (<65 years) groups and compared with age-matched healthy volunteers, with critically ill non-septic patients providing an additional disease control group. Metabolite concentrations and pathway-related ratios will be analyzed in relation to cytotoxic γδ T-cell abundance, cytotoxic function, mitochondrial OXPHOS, and COX6C expression, accounting for renal function, disease severity, antibiotic exposure, and nutritional support. These analyses will assess whether age-associated alterations in tryptophan metabolism, particularly KYNA, are associated with cytotoxic γδ T-cell dysfunction and identify candidate metabolic mechanisms for subsequent validation.
- Conditions
- Sepsis, Critical Illness, Immunosuppression, MODS, Mitochondrial Diseases, Dysbiosis
- Medical subject headings
- Sepsis, Critical Illness, Multiple Organ Failure, Mitochondrial Diseases, Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls (NHCs) | Healthy volunteers without acute or chronic major diseases, aged ≥18 years, who have provided written informed consent. Participants undergo a single blood draw and rectal swab collection. | |
| Critically Ill Non-Septic Patients (CI-NS) | Patients admitted to the ICU meeting the criteria for critical illness but without sepsis, as determined by the Sepsis-3 criteria (infection with ΔSOFA ≥ 2 points excluded). Participants are aged ≥18 years, with informed consent obtained from the patient or legally authorized representative. Blood and rectal swab samples are collected at three time points: within 24 hours of ICU admission (D0), Day 2 (D2), and Day 7 (D7). Clinical follow-up extends to 90 days. | |
| Critically Ill Septic Patients (CI-Sep) | Patients admitted to the ICU meeting the Sepsis-3 criteria (infection with ΔSOFA ≥ 2 points). Participants are aged ≥18 years, with informed consent obtained from the patient or legally authorized representative. Blood and rectal swab samples are collected at three time points: within 24 hours of ICU admission (D0), Day 2 (D2), and Day 7 (D7). Clinical follow-up extends to 90 days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Proportion of Cytotoxic γδT Cells (TCRγδ⁺GZMB⁺PRF1⁺GNLY⁺) Among Total γδT Cells
Flow cytometric quantification of the frequency of Cytotoxic γδT cells, defined as TCRγδ⁺GZMB⁺PRF1⁺GNLY⁺ cells, as a percentage of total γδT cells (TCRγδ⁺) in peripheral blood. This subset represents the cytotoxic effector population critical for early anti-infection defense.
Measured: Within day 2 post-ICU admission
Secondary outcomes (26)
Change in COX6C Expression in Cytotoxic γδT Cells
Measurement of COX6C (mitochondrial respiratory chain complex IV subunit) expression levels in Cytotoxic γδT cells (TCRγδ⁺GZMB⁺PRF1⁺GNLY⁺) at the mRNA level (by single-cell RNA sequencing) and protein level (by flow cytometry).
Measured: Within day 2 post-ICU admission
Blood Kynurenic Acid Level
Peripheral blood KYNA concentration will be quantified using targeted tryptophan-pathway metabolomics by LC-MS/MS and compared among older patients with sepsis (≥65 years), non-older adult patients with sepsis (<65 years), and healthy volunteers.
Measured: Within day 2 post-ICU admission
Fecal Kynurenic Acid Level
Fecal KYNA concentration will be quantified using targeted tryptophan-pathway metabolomics by LC-MS/MS and compared among older patients with sepsis (≥65 years), non-older adult patients with sepsis (<65 years), and healthy volunteers.
Measured: Within day 2 post-ICU admission
Blood Kynurenic Acid Levels and Their Associations With Cytotoxic γδ T-Cell Function
Associations between peripheral blood KYNA concentrations, quantified by targeted LC-MS/MS, and prespecified quantitative measures of cytotoxic γδ T-cell function will be assessed in older patients with sepsis (≥65 years), non-older adult patients with sepsis (<65 years), and healthy volunteers.
Measured: Within day 2 post-ICU admission
Fecal Kynurenic Acid Levels and Their Associations With Cytotoxic γδ T-Cell Function
Associations between fecal KYNA concentrations, quantified by targeted LC-MS/MS, and prespecified quantitative measures of circulating cytotoxic γδ T-cell function will be assessed in older patients with sepsis (≥65 years), non-older adult patients with sepsis (<65 years), and healthy volunteers.
Measured: Within day 2 post-ICU admission
Change in Cytotoxic Molecule Expression in Cytotoxic γδT Cells
Flow cytometric quantification of the mean fluorescence intensity (MFI) of cytotoxic effector molecules including Granzyme B (GZMB), Perforin (PRF1), and Granulysin (GNLY) in Cytotoxic γδT cells (TCRγδ⁺GZMB⁺PRF1⁺GNLY⁺).
Measured: Within day 2 post-ICU admission
Change in Mitochondrial Mass in Cytotoxic γδT Cell
Flow cytometric quantification of mitochondrial mass using MitoTracker Green FM staining in Cytotoxic γδT cells (TCRγδ⁺GZMB⁺PRF1⁺GNLY⁺).
Measured: Within day 2 post-ICU admission
Change in Mitochondrial Membrane Potential (TMRE) in Cytotoxic γδT Cells
Flow cytometric quantification of mitochondrial membrane potential using tetramethylrhodamine ethyl ester (TMRE) staining in Cytotoxic γδT cells (TCRγδ⁺GZMB⁺PRF1⁺GNLY⁺).
Measured: Within day 2 post-ICU admission
Change in Mitochondrial Membrane Potential (JC-1) in Cytotoxic γδT Cells
Flow cytometric quantification of mitochondrial membrane potential using JC-1 dye (red/green fluorescence ratio) in Cytotoxic γδT cells (TCRγδ⁺GZMB⁺PRF1⁺GNLY⁺).
Measured: Within day 2 post-ICU admission
Change in Oxygen Consumption Rate (OCR) in Cytotoxic γδT Cells
Measurement of basal oxygen consumption rate reflecting oxidative phosphorylation (OXPHOS) capacity in Cytotoxic γδT cells (TCRγδ⁺GZMB⁺PRF1⁺GNLY⁺).
Measured: Within day 2 post-ICU admission
Change in Extracellular Acidification Rate (ECAR) in Cytotoxic γδT Cells
Measurement of basal extracellular acidification rate reflecting glycolytic metabolic activity in Cytotoxic γδT cells (TCRγδ⁺GZMB⁺PRF1⁺GNLY⁺).
Measured: Within day 2 post-ICU admission
Change in Glycolytic Capacity of Cytotoxic γδT Cells at Serial Time Points
Longitudinal flow cytometric puromycin-incorporation assay (SCENITH method) to measure glycolytic capacity in Cytotoxic γδT cells (TCRγδ⁺GZMB⁺PRF1⁺GNLY⁺) at Day 0, Day 2, and Day 7 post-ICU admission, to track the temporal evolution of metabolic flexibility and stress-adaptive glycolytic reprogramming during the course of critical illness.
Measured: Day 0, Day 2, and Day 7 post-ICU admission
Change in Mitochondrial ROS Levels in Cytotoxic γδT Cells at Serial Time Points
Longitudinal flow cytometric quantification of mitochondrial reactive oxygen species (mitochondrial ROS) levels using MitoSOX Green staining in Cytotoxic γδT cells (TCRγδ⁺GZMB⁺PRF1⁺GNLY⁺) at Day 0, Day 2, and Day 7 post-ICU admission, reflecting oxidative stress dynamics.
Measured: Day 0, Day 2, and Day 7 post-ICU admission
Change in Cytotoxic γδT Cell Migratory Function
Assessment of Cytotoxic γδT cell (TCRγδ⁺GZMB⁺PRF1⁺GNLY⁺) chemotactic and migratory capacity using Transwell migration assay.
Measured: Within day 2 post-ICU admission
Change in Total γδT Cell Proportion at Serial Time Points
Longitudinal flow cytometric quantification of the frequency of total γδT cells (TCRγδ⁺) as a percentage of total live CD3⁺ T cells in peripheral blood at Day 0, Day 2, and Day 7 post-ICU admission.
Measured: Day 0, Day 2, and Day 7 post-ICU admission
Change in Cytotoxic γδT Cell Proportion at Serial Time Points
Longitudinal flow cytometric quantification of the frequency of Cytotoxic γδT cells (TCRγδ⁺GZMB⁺PRF1⁺GNLY⁺) as a percentage of total γδT cells at Day 0, Day 2, and Day 7 post-ICU admission, to track the temporal evolution of this cell subset.
Measured: Day 0, Day 2, and Day 7 post-ICU admission
Change in COX6C Expression in Cytotoxic γδT Cells at Serial Time Points
Longitudinal measurement of COX6C expression levels in Cytotoxic γδT cells (TCRγδ⁺GZMB⁺PRF1⁺GNLY⁺) at Day 0, Day 2, and Day 7 post-ICU admission, to assess the temporal dynamics of mitochondrial metabolic gene expression.
Measured: Day 0, Day 2, and Day 7 post-ICU admission
Correlation Between Cytotoxic γδT Cell Glycolytic Capacity and APACHE II Score
Spearman rank correlation analysis between glycolytic capacity (measured by puromycin incorporation assay at Day 2) in Cytotoxic γδT cells (TCRγδ⁺GZMB⁺PRF1⁺GNLY⁺) with APACHE II (Acute Physiology and Chronic Health Evaluation II) score measured within the first 48 hours of ICU admission.
Measured: Within day 2 post-ICU admission
Correlation Between Cytotoxic γδT Cell Glycolytic Capacity and SOFA Score
Spearman rank correlation analysis between glycolytic capacity (measured by puromycin incorporation assay at Day 2) in Cytotoxic γδT cells (TCRγδ⁺GZMB⁺PRF1⁺GNLY⁺) with SOFA (Sequential Organ Failure Assessment) score measured within the first 48 hours of ICU admission.
Measured: Within day 2 post-ICU admission
Correlation Between Cytotoxic γδT Cell Metabolic Parameters and vasopressor dose
Correlation analysis between COX6C expression, glycolytic capacity, and mitochondrial ROS levels in Cytotoxic γδT cells (TCRγδ⁺GZMB⁺PRF1⁺GNLY⁺) with vasopressor dose (reported as norepinephrine equivalent dose, NEE).
Measured: Within day 2 post-ICU admission
Correlation Between Cytotoxic γδT Cell Metabolic Parameters and plasma lactate levels
Correlation analysis between COX6C expression, glycolytic capacity, and mitochondrial ROS levels in Cytotoxic γδT cells (TCRγδ⁺GZMB⁺PRF1⁺GNLY⁺) with plasma lactate levels.
Measured: Within day 2 post-ICU admission
Association Between Cytotoxic γδT Cell Glycolytic Capacity and 28-day all-cause mortality
Analysis of association between glycolytic capacity (measured at Day 2) in Cytotoxic γδT cells (TCRγδ⁺GZMB⁺PRF1⁺GNLY⁺) and 28-day all-cause mortality. Patients will be stratified by vital status (survivors vs. non-survivors) and by hospital length of stay (above vs. below median) for comparative analysis.
Measured: Up to 90 days post-discharge
Association Between Cytotoxic γδT Cell Glycolytic Capacity and 90-day all-cause mortality
Analysis of association between glycolytic capacity (measured at Day 2) in Cytotoxic γδT cells (TCRγδ⁺GZMB⁺PRF1⁺GNLY⁺) and 90-day all-cause mortality. Patients will be stratified by vital status (survivors vs. non-survivors) and by hospital length of stay (above vs. below median) for comparative analysis.
Measured: Up to 90 days post-discharge
Association Between Cytotoxic γδT Cell Glycolytic Capacity and in-hospital mortality
Analysis of association between glycolytic capacity (measured at Day 2) in Cytotoxic γδT cells (TCRγδ⁺GZMB⁺PRF1⁺GNLY⁺) and in-hospital mortality. Patients will be stratified by vital status (survivors vs. non-survivors) and by hospital length of stay (above vs. below median) for comparative analysis.
Measured: Up to 90 days post-discharge
Association Between Cytotoxic γδT Cell Glycolytic Capacity and ICU mortality
Analysis of association between glycolytic capacity (measured at Day 2) in Cytotoxic γδT cells (TCRγδ⁺GZMB⁺PRF1⁺GNLY⁺) and ICU mortality. Patients will be stratified by vital status (survivors vs. non-survivors) and by hospital length of stay (above vs. below median) for comparative analysis.
Measured: Up to 90 days post-discharge
Association Between Cytotoxic γδT Cell Glycolytic Capacity and hospital length of stay
Analysis of association between glycolytic capacity (measured at Day 2) in Cytotoxic γδT cells (TCRγδ⁺GZMB⁺PRF1⁺GNLY⁺) and hospital length of stay (days). Patients will be stratified by vital status (survivors vs. non-survivors) and by hospital length of stay (above vs. below median) for comparative analysis.
Measured: Up to 90 days post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start21 Jun 2026
- Primary completion15 Apr 2027 (estimated)
- Study completion15 Jul 2027 (estimated)
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.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiancheng Zhang, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07680816
- Sponsor's protocol ID
- zjc202612
- Status last verified
- Oct 2026
- First submitted
- 25 Jun 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subset-specific Metabolic Adaptation and Functional Remodeling of Gamma Delta T (γδ T) Cells in Critically Ill ICU Patients: A Single-center, Prospective, Observational Cohort Study.
- ClinicalTrials.gov ID
- NCT07680816
- Acronym / sponsor ID
- zjc202612
- Conditions
- Sepsis, Critical Illness, Immunosuppression, MODS, Mitochondrial Diseases, Dysbiosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 21 Jun 2026 (actual)
- Primary completion
- 15 Apr 2027 (estimated)
- Study completion
- 15 Jul 2027 (estimated)
- First posted
- 2 Jul 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 prospective observational cohort study investigates the subset-specific metabolic adaptation and functional remodeling of cytotoxic γδ T cells in critically ill patients with and without sepsis. As a bridge between innate and adaptive immunity, γδ T cells contribute to early antimicrobial defense; however, their cytotoxic function and its metabolic regulation in sepsis remain incompletely understood. Our preliminary single-cell transcriptomic analysis revealed altered expression of cytotoxicity-associated genes (GZMB, PRF1, and GNLY) and mitochondrial oxidative phosphorylation (OXPHOS) pathway genes in cytotoxic γδ T cells from patients with sepsis. In particular, COX6C expression correlated with cytotoxic effector gene expression. Across healthy volunteers, critically ill non-septic patients, and critically ill septic patients, we will integrate flow cytometry, mitochondrial function assays, and functional validation experiments to characterize circulating cytotoxic γδ T-cell abundance and function and examine the contribution of COX6C to mitochondrial dysfunction and impaired cytotoxicity.
To investigate the relationship between systemic tryptophan metabolism and these cellular abnormalities, targeted tryptophan-pathway metabolomics using liquid chromatography-tandem mass spectrometry (LC-MS/MS) will quantify kynurenic acid (KYNA), tryptophan, kynurenine, and related metabolites in paired peripheral blood and fecal samples. Patients with sepsis will be stratified into older (≥65 years) and non-older (<65 years) groups and compared with age-matched healthy volunteers, with critically ill non-septic patients providing an additional disease control group. Metabolite concentrations and pathway-related ratios will be analyzed in relation to cytotoxic γδ T-cell abundance, cytotoxic function, mitochondrial OXPHOS, and COX6C expression, accounting for renal function, disease severity, antibiotic exposure, and nutritional support. These analyses will assess whether age-associated alterations in tryptophan metabolism, particularly KYNA, are associated with cytotoxic γδ T-cell dysfunction and identify candidate metabolic mechanisms for subsequent validation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls (NHCs) | – | –Healthy volunteers without acute or chronic major diseases, aged ≥18 years, who have provided written informed consent. Participants undergo a single blood draw and rectal swab collection. |
| Critically Ill Non-Septic Patients (CI-NS) | – | –Patients admitted to the ICU meeting the criteria for critical illness but without sepsis, as determined by the Sepsis-3 criteria (infection with ΔSOFA ≥ 2 points excluded). Participants are aged ≥18 years, with informed consent obtained from the patient or legally authorized representative. Blood and rectal swab samples are collected at three time points: within 24 hours of ICU admission (D0), Day 2 (D2), and Day 7 (D7). Clinical follow-up extends to 90 days. |
| Critically Ill Septic Patients (CI-Sep) | – | –Patients admitted to the ICU meeting the Sepsis-3 criteria (infection with ΔSOFA ≥ 2 points). Participants are aged ≥18 years, with informed consent obtained from the patient or legally authorized representative. Blood and rectal swab samples are collected at three time points: within 24 hours of ICU admission (D0), Day 2 (D2), and Day 7 (D7). Clinical follow-up extends to 90 days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population comprises three distinct groups: healthy volunteers, non-septic critically ill patients, and septic critically ill patients admitted to the intensive care unit. Sepsis is defined according to the Sepsis-3 criteria (infection with an acute increase in SOFA score ≥2 points), while critical illness is based on standard ICU admission criteria. All participants must be aged ≥18 years and provide written informed consent (from the participant or a legally authorized representative for those unable to consent). Key exclusion criteria include known immunodeficiency, recent use of T-cell-targeted immunosuppressants or immune checkpoint inhibitors, expected ICU stay <24 hours, pregnancy, active major bleeding, or inability to obtain consent. Consecutive enrollment will take place at the Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, with follow-up through 90 days after enrollment.
Key inclusion criteria (13 listed)
- Healthy Control Group (NHC):
- Non-septic Critical Illness Group (CI-NS):
- Septic Critical Illness Group (CI-Sep):
Key exclusion criteria (8 listed)
- Age < 18 years.
- Known immunodeficiency, HIV infection, active hematologic malignancy, or history of hematopoietic stem cell or solid organ transplantation within the past 3 months.
- Receipt of T-cell-targeted immunosuppressive therapy (e.g., antithymocyte globulin, calcineurin inhibitors, mycophenolate mofetil, methotrexate, or high-dose corticosteroids >1 mg/kg/day prednisone equivalent) before ICU admission or within 24 hours after ICU admission.
- Use of immune checkpoint inhibitors (e.g., anti-PD-1/PD-L1/CTLA-4 antibodies) within the past 6 weeks.
- Expected ICU stay < 24 hours or imminent risk of death (moribund state).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in the Proportion of Cytotoxic γδT Cells (TCRγδ⁺GZMB⁺PRF1⁺GNLY⁺) Among Total γδT Cells
Time frame: Within day 2 post-ICU admission
Flow cytometric quantification of the frequency of Cytotoxic γδT cells, defined as TCRγδ⁺GZMB⁺PRF1⁺GNLY⁺ cells, as a percentage of total γδT cells (TCRγδ⁺) in peripheral blood. This subset represents the cytotoxic effector population critical for early anti-infection defense.
26 secondary outcomes
Change in COX6C Expression in Cytotoxic γδT Cells
Time frame: Within day 2 post-ICU admission
Blood Kynurenic Acid Level
Time frame: Within day 2 post-ICU admission
Fecal Kynurenic Acid Level
Time frame: Within day 2 post-ICU admission
Blood Kynurenic Acid Levels and Their Associations With Cytotoxic γδ T-Cell Function
Time frame: Within day 2 post-ICU admission
Fecal Kynurenic Acid Levels and Their Associations With Cytotoxic γδ T-Cell Function
Time frame: Within day 2 post-ICU admission
Change in Cytotoxic Molecule Expression in Cytotoxic γδT Cells
Time frame: Within day 2 post-ICU admission
Change in Mitochondrial Mass in Cytotoxic γδT Cell
Time frame: Within day 2 post-ICU admission
Change in Mitochondrial Membrane Potential (TMRE) in Cytotoxic γδT Cells
Time frame: Within day 2 post-ICU admission
Change in Mitochondrial Membrane Potential (JC-1) in Cytotoxic γδT Cells
Time frame: Within day 2 post-ICU admission
Change in Oxygen Consumption Rate (OCR) in Cytotoxic γδT Cells
Time frame: Within day 2 post-ICU admission
Change in Extracellular Acidification Rate (ECAR) in Cytotoxic γδT Cells
Time frame: Within day 2 post-ICU admission
Change in Glycolytic Capacity of Cytotoxic γδT Cells at Serial Time Points
Time frame: Day 0, Day 2, and Day 7 post-ICU admission
Change in Mitochondrial ROS Levels in Cytotoxic γδT Cells at Serial Time Points
Time frame: Day 0, Day 2, and Day 7 post-ICU admission
Change in Cytotoxic γδT Cell Migratory Function
Time frame: Within day 2 post-ICU admission
Change in Total γδT Cell Proportion at Serial Time Points
Time frame: Day 0, Day 2, and Day 7 post-ICU admission
Change in Cytotoxic γδT Cell Proportion at Serial Time Points
Time frame: Day 0, Day 2, and Day 7 post-ICU admission
Change in COX6C Expression in Cytotoxic γδT Cells at Serial Time Points
Time frame: Day 0, Day 2, and Day 7 post-ICU admission
Correlation Between Cytotoxic γδT Cell Glycolytic Capacity and APACHE II Score
Time frame: Within day 2 post-ICU admission
Correlation Between Cytotoxic γδT Cell Glycolytic Capacity and SOFA Score
Time frame: Within day 2 post-ICU admission
Correlation Between Cytotoxic γδT Cell Metabolic Parameters and vasopressor dose
Time frame: Within day 2 post-ICU admission
Correlation Between Cytotoxic γδT Cell Metabolic Parameters and plasma lactate levels
Time frame: Within day 2 post-ICU admission
Association Between Cytotoxic γδT Cell Glycolytic Capacity and 28-day all-cause mortality
Time frame: Up to 90 days post-discharge
Association Between Cytotoxic γδT Cell Glycolytic Capacity and 90-day all-cause mortality
Time frame: Up to 90 days post-discharge
Association Between Cytotoxic γδT Cell Glycolytic Capacity and in-hospital mortality
Time frame: Up to 90 days post-discharge
Association Between Cytotoxic γδT Cell Glycolytic Capacity and ICU mortality
Time frame: Up to 90 days post-discharge
Association Between Cytotoxic γδT Cell Glycolytic Capacity and hospital length of stay
Time frame: Up to 90 days post-discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
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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.
Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
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 and Critical Illness, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 13 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 27 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Proportion of Cytotoxic γδT Cells (TCRγδ⁺GZMB⁺PRF1⁺GNLY⁺) Among Total γδT Cells (time frame: Within day 2 post-ICU admission). 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 27 Oct 2026.