Tumor sepsis
Conditions
Interventions
Experimental group:clinical treatment protocol+Carrimycin tablets(400mg/day)
Control group:clinical treatment protocol+placebo tablets(400mg/day)
Sponsors
The First Affiliated Hospital of Harbin Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects or their legal representatives have signed the ICF; 2. Subjects aged 18 to 75 years; 3. Subjects meet the diagnostic criteria of Sepsis 3.0; 4. SOFA score: 2 ~ 13 points; 5. Patients with malignant tumor (histodiagnosis).
Exclusion criteria
Exclusion criteria: 1. Sepsis has been clearly diagnosed for more than 48 hours; 2. Tumor sepsis is combined with other severe primary diseases that affect survival, including blood diseases, hematologic neoplasms, lymphoma, HIV, etc.; 3. Patients having liver and kidney dysfunction, and with SOFA score =3 points for single item of liver or kidney function; 4. Patients have received tumor immunotherapy (such as PD-1 / L1, CTLA4, etc.) in the past 1 month, or those who often use immunomodulators such as thymosin, and inflammatory factor modulators such as Ulinastatin; 5. Patients who have received organ transplantation in the past 6 months; 6. Patients who can't be given gastrointestinal diet or administration, for example, due to intestinal obstruction, etc; 7. Women subjects that are pregnant or lactating, or subjects (including male subjects) having a pregnancy plan (including plans for sperm donation or egg donation), or subjects that may fail to take effective contraceptive measures within the next 6 month; 8. Patients who have participated in any other clinical trial within 1 month; 9. The investigators conclude that the patients not suitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| inflammatory factors (IL-6, IL-8, IL-10, TNF-alpha);Human leukocyte surface antigen-DR;programmed cell death protein 1 (PD-1);T cell PD-1 expression;MDSC (myeloid suppressor cells);T cell subsets (CD4+ and CD8+ T cells); | — |
Secondary
| Measure | Time frame |
|---|---|
| All-cause mortality (28 days);All-cause mortality (7 days);SOFA score;APACHE II score;Duration of mechanical ventilation;ICU period;CRRT duration;C-reactive protein;Procalcitonin; | — |
Countries
China
Contacts
Public ContactKaijiang Yu
The First Affiliated Hospital of Harbin Medical University
Outcome results
None listed