Septic Shock
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) 18 years old = age =80 years old, gender is not limited; (2) For patients diagnosed with septic shock within 72 hours, see [International Guidelines for the Management of Sepsis and Septic Shock, 2021] for diagnostic criteria; (3) IL-6=500 pg/ml; (4) If the patient agrees to participate in the study, the patient's family members or patients sign the informed consent voluntarily.
Exclusion criteria
Exclusion criteria: (1) Patients with congenital or acquired immunodeficiency diseases, or those who have received organ transplantation within 1 year before enrollment; (2) Patients who had received immunosuppressive drugs within 30 days before inclusion, or had used tocilizumab within 3 months before inclusion; (3) Patients undergoing absorbent blood purification therapy (such as cytokine adsorption column, polymyxin B adsorption column, oXiris filter, etc.) or plasma exchange therapy; (4) Patients who had used ulinastatin, cilvelestat sodium and other cytokines and inflammatory response regulating drugs within 24h before inclusion or within 6h after starting treatment; (5) Patients with severe coagulation dysfunction (INR > 2 times) and difficult to correct, or acute massive bleeding that cannot be controlled within 24 hours; (6) End-stage organ failure or wasting diseases such as malignant tumors; (7) Allergic to anticoagulants, agarose, nano-antibodies, adsorption column composition materials or pipelines or other serious allergic history; (8) Pregnant or lactating women; (9) Patients who have participated in clinical trials of other drugs or medical devices within 30 days prior to enrollment; (10) Other patients deemed unsuitable for this trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Elimination rate of serum IL-6 after 6h treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Total amount and proportion of IL-6 eluted from adsorption column after treatment;Changes in IL-6 serum levels from baseline to 3 hours after initiation of treatment;Changes in PCT serum levels from baseline to 24 hours after treatment initiation;Changes in blood lactate levels from baseline to 24 hours after initiation of treatment;Changes in SOFA score from baseline to 24 hours after starting treatment;Changes in CRP serum levels from baseline to 24 hours after treatment initiation; | — |
Countries
China
Contacts
West China Hospital of Sichuan University