Infectious disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Infected patients with an etiological basis such as biological sample culture or nucleic acid 2. Increased circulating cytokines (5 times or more of any one cytokine) 3. Meet the diagnostic criteria for systemic inflammatory syndrome (meet any two criteria: body temperature above 38 degrees Celsius or below 36 degrees Celsius; Heart rate > 90 beats/min; Respiration rate more than 20 times/min or CO2 partial pressure less than 32 mmHg;White blood cell count > 12000/µL or 10%.); 4. SOFA score of any organ (liver, kidney, brain, respiratory, circulation, coagulation) is greater than or equal to 1.
Exclusion criteria
Exclusion criteria: The first part of the observational study: 1. Under the age of 15; 2. Pregnant women; 3. Malignant tumor; 4. Active stage of inflammatory diseases and rheumatic immune diseases; 5. Used CAR T or other cell biotherapy in the last six months. The fifth part of the intervention study: 1.Pregnant women; 2.The patient or family member does not agree to sign the informed consent; 3.There are comorbidities, such as malignant tumors or long-term immunosuppressants, which affect the evaluation of the efficacy of this treatment; 4.The investigators determined that the patient had other conditions that were not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| cytokines;Part I: 28-day case fatality rate;Part 5:28-day severe/critical case fatality rate;Part Five: Improvement rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immune cell subsets;Metabolite;Microbiomics;Part I: Incidence of organ failure within 28 days;Part Five: Incidence of shock;Part Five: The incidence of multiple organ failure;Part Five: Length of stay;Part Five: Length of stay in ICU; | — |
Countries
China
Contacts
The First Affiliated Hospital, College of Medicine, Zhejiang University