Sepsis
Conditions
Interventions
Intervention Group:Thymosin a1 (1.6 mg, subcutaneous injection, twice a week, for a maximum duration of 12 weeks)
Control group:Normal saline (1ml, subcutaneous injection, twice a week, for a maximum duration of 12 weeks)
Sponsors
The First Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
60 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Aged 60 to 85 years. 2. First episode of sepsis. 3. With the infection under control (pathogen clearance or clinically judged as colonization, having discontinued antibiotics, or planned for sequential oral antibiotic therapy).
Exclusion criteria
Exclusion criteria: 1.Discharge against medical advice due to worsening of the condition. 2.Life expectancy due to the primary disease is less than 6 months. 3.History of solid organ or hematologic malignancy, or bone marrow transplantation. 4.Active connective tissue disease (e.g., rheumatoid diseases, systemic lupus erythematosus) or chronic kidney disease. 5.Long-term use of corticosteroids or immunosuppressive drugs. 6.Participation in other studies involving immunomodulatory drugs. 7.Allergy to thymosin a1 or thymopentin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment Compliance; | — |
Secondary
| Measure | Time frame |
|---|---|
| 90-day Unplanned Readmission Rate;90-day Sepsis Recurrence Rate;90-day Mortality Rate;90-day SF-36 Quality of Life (QOL) Score;Change from baseline (pre-treatment) in mHLA-DR post-treatment (at 30±3 days and 90±7 days);Change from baseline (pre-treatment) in lymphocyte count post-treatment (at 30±3 days and 90±7 days);Change from baseline (pre-treatment) in the neutrophil-to-lymphocyte ratio post-treatment (at 30±3 days and 90±7 days); | — |
Countries
China
Contacts
Public ContactPei Fei
The First Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed