Efficacy and Safety Study of CA330 Hemoadsorption Device on IL-6 Removal in Septic Patients

This is an interventional treatment trial for Sepsis focused on measuring sepsis, IL-6, hemoperfusion Read More

Inclusion Criteria:

1. Hospitalized patients aged 18-75 years, regardless of gender;
2. Meet the clinical criteria of sepsis according to the Third International Consensus Definitions for Sepsis;
3. The diagnosis of sepsis is established within last 48 hours.
4. Written informed consent is signed, and agreement to participate in all visits, examinations and treatments as required by the research program is achieved. If a patient is not able to give consent, the legal representative is asked to consent.

Exclusion Criteria:

1. End-stage renal disease that need maintenance hemodialysis treatment;
2. Congenital or acquired immunodeficiency disorders or those who had received organ transplantation within one year;
3. Prescription of immunosuppressive medications (tripterygium wilfordii, mycophenolate mofetil, cyclophosphamide, FK506, etc.) or prednisolone for more than 10 mg/day (or the same dose of other hormone therapy) within 30 days;
4. Coagulation dysfunction, severe bleeding tendency (prothrombin time, activated partial thromboplastin time prolonged significantly with bleeding, or fibrinogen less than 1.2 g/L with bleeding), active bleeding or uncontrolled acute massive bleeding within 24 hours;
5. Malignant tumors, consumptive diseases, site of infection cannot be cleared (ie surgical patients who cannot be operated on) or body weight less than 35kg;
6. A terminal state of organ failure (end stage of chronic obstructive pulmonary disease, pulmonary heart disease, heart dysfunction stage-IV, brain death or persistent vegetative state, chronic liver disease with hepatic encephalopathy, coagulation dysfunction, fluid retention and hepatocellular jaundice);
7. Following results are detected during screening: platelet count < 50 *10^9/L, neutrophil count < 0.5 *10^9/L, hemoglobin < 70 g/L;
8. Despite of adequate volume resuscitation, vasopressors and hormones, the mean arterial blood cannot maintain above 65 mmHg;
9. Those who have been participating in or participated in another interventional clinical study within 30 days prior to enrollment, such as the clinical study of related drugs or medical devices affecting immunity (ie Xuebijing, ulinastatin, continuous renal replacement therapy, etc.);
10. Anaphylaxis to materials of cardiopulmonary bypass, anticoagulants and hemoperfusion or other serious allergic history;
11. Those who are not suitable for this clinical trial, which is determined by researchers, such as pregnant or lactating women, current drug addicts, patients with severe mental or neurological disorders, and those who have a history of alcohol abuse and cannot be terminated.