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Study on the mechanism of spleen-derived extracellular vesicles in peripheral blood exacerbating lung infection in late sepsis

Mechanism study on spleen-derived CCR1+ extracellular vesicles mediating "spleen-lung" axis communication exacerbating lung infection in late sepsis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600118496
Enrollment
Unknown
Registered
2026-02-06
Start date
2026-02-06
Completion date
Unknown
Last updated
2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

Interventions

Sepsis patient cohort and healthy control group cohort:None

Sponsors

The first affiliated hostipal of nanchang university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Sepsis patient cohort: (1) Patients diagnosed with sepsis or septic shock within 24 hours after admission to the ICU according to the Sepsis 3.0 guidelines; (2) Age >= 18 years old, gender not limited; (3) The patient or his/her authorized agent/family member fully understands the content of this study and voluntarily signs the written informed consent form for clinical research. 2. Healthy control group cohort: (1) Healthy volunteers whose age and gender were matched with those in the sepsis patient cohort; (2) The results of physical examination and routine laboratory tests (blood routine, liver and kidney function, etc.) are within the normal range. (3) I fully understand the content of this research and voluntarily sign the written informed consent form for clinical research

Exclusion criteria

Exclusion criteria: 1. Sepsis patient cohort: (1) There is a clear background disease or condition that affects immune function, such as: human immunodeficiency virus (HIV) infection; (2) Those who have been taking immunosuppressants for a long time after solid organ or bone marrow transplantation; (3) Those with blood system diseases who have been taking immunosuppressants for a long time; (4) Suffering from primary immunodeficiency diseases; (5) Patients with malignant tumors who are currently receiving or have received chemotherapy or radiotherapy within 3 months prior to enrollment; (6) Those who need to take high-dose glucocorticoids (>15mg/d prednisone or equivalent doses) or immunosuppressants for a long time (>1 month) due to autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, etc.); (7) Pregnant or lactating women; (8) The patient is currently participating in other drug or interventional clinical trials that may affect the results of this study at the same time; (9) The researcher determined that the patient or their authorized agent/family member refused to sign the informed consent form. 2. Healthy control group cohort: (1) Had any acute infectious diseases (such as cold, diarrhea, etc.) within 2 weeks before screening; (2) Have a history of chronic infectious diseases (such as chronic hepatitis B/C, tuberculosis, etc.); (3) Pregnant or lactating women; (4) Have a history of malignant tumors, autoimmune diseases or immune deficiencies; (5) Long-term use of any drugs that may affect immune function (such as glucocorticoids, immunosuppressants, etc.); (6) Have a history of drug abuse or alcohol dependence

Design outcomes

Primary

MeasureTime frame
28-day all-cause mortality;

Secondary

MeasureTime frame
Immune suppression status indicators (including but not limited to absolute lymphocyte count in peripheral blood, HLA-DR expression level on monocytes);Clinical prognosis indicators (including ICU length of stay, total hospital length of stay, 90-day mortality, long-term survival rate);Organ dysfunction assessment (dynamic changes in SOFA score);In-hospital complications (incidence rates of secondary infections, acute respiratory distress syndrome, acute kidney injury, etc.);Incidence rate of persistent inflammation, immunosuppression, and catabolism syndrome (PICS);

Countries

China

Contacts

Public ContactBai Songjie

The first affiliated hostipal of nanchang university

songjie.bai@ncu.edu.cn+86 791 86427278

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 15, 2026