Sepsis
Conditions
Interventions
experimental group:1ml subcutaneous injection with 1.6 mg thymosin every 12±2 hours and 20ml intravenous injection with 200,000 units ulinastatin every 8±1 hours
Control group:1ml subcutaneous injection with normal saline every 12±2 hours and 20ml intravenous injection with normal saline every 8±1 hours
Sponsors
The First Affiliated Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
60 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. 60 150Mg/L, Lymphocytes<0.9×10^9/L).
Exclusion criteria
Exclusion criteria: 1. Patients who having experienced sepsis within the past three months before randomization or participation in other interventional clinical trials; 2. Patients who have used ulinastatin or thymosin-related drugs within one month before the screening period, or undergoing radiotherapy and/or chemotherapy; 3. Patients with history of solid organ (liver, kidney, heart, lung) or bone marrow transplantation; 4. Patients who have hematologic malignancies or HIV infection; 5. Patients with active connective tissue diseases (e.g., rheumatoid diseases, systemic lupus erythematosus) and chronic kidney disease; 6. Patients with history of treatment with =3 mg dexamethasone (or corticosteroid equivalent) for >1 week. or immunosuppressive drugs (e.g., tumor necrosis factor-alpha inhibitors, methotrexate, azathioprine, and mycophenolate mofetil); 7. Patient with history of allergy or intolerance to thymalfasin or ulinastatin; 8. Patients with intracranial infection, infective endocarditis, graft infection, or an identified infection site during screening that cannot be cleared; 9. Patients with refractory shock during screening (unable to maintain MAP >= 65 mmHg with norepinephrine > 0.5 µg/kg/min standard equivalent; persistent lactate rise; continued deterioration of organ perfusion) 10. Patients with granulocytopenia during screening (neutrophil count < 1.0 × 10^9/L); 11. Patients with decision to withhold or withdraw life-sustaining treatment, i.e., abandoning treatment; 12. Patients who had cardiopulmonary resuscitation within 72 hours before randomization with unrecovered neurological function (GCS < 8); 13. Pregnancy or lactation period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in mean SOFA 2 score (Days 1-7) from baseline;dynamic change of IL-6; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of decline in mean daily SOFA 2score (Days 1–7) from baseline.;Proportion of decline in mean SOFA2 score (Days 1–14) from baseline.;ICU mortality rate;In-hospital mortality rate;28-day mortality rate;Mechanical ventilation-free days within 28 days;Vasoactive drugs-free days within 28 days;CRRT-free days within 28 days;New-onset infections in the ICU;dynamic change of lymphocytes counts;dynamic change of Neutrophil to Lymphocyte Ratio;dynamic change of C-reactive protein;dynamic change of monocyte human leukocyte antigen-DR; | — |
Countries
China
Contacts
Public ContactJianfeng Wu
The First Affiliated Hospital, Sun Yat-sen University
Outcome results
None listed