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Efficacy and safety of a novel IL-6-selective adsorption column (ASIL6) on IL-6 elimination in septic patients: a randomized controlled trial

Efficacy and safety of a novel IL-6-selective adsorption column (ASIL6) on IL-6 elimination in septic patients: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083179
Enrollment
Unknown
Registered
2024-04-17
Start date
2024-04-22
Completion date
Unknown
Last updated
2024-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septic Shock

Interventions

experimental group:IL-6 adsorption column + conventional treatment

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

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

MeasureTime frame
Elimination rate of serum IL-6 after 6h treatment;

Secondary

MeasureTime 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

Public ContactKang Yan

West China Hospital of Sichuan University

kangyan_hx@163.com+86 189 8060 1566

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026