sepsis
Conditions
Interventions
blood adsorption treatment group:blood adsorption treatment + conventional treament
conventional treament control group:conventional treament
Sponsors
NanFang Hospital of Southem Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)18-85 years old(contained boundary value); 2)Diagnosed with sepsis by SEPSIS 3.0; 3)IL-6 level =1000pg/mL; 4)Agreed to attend all visits and treatments as required by the study protocol, and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1)Patients with congenital or acquired immunodeficiency diseases, or who had received organ transplants within 1 year prior to inclusion; 2)Estimated survival time less than 72 hours; 3)Platelet counts were still less than 30x10^9/L after transfusion therapy, in screening period; 4)Patients with coagulation disorders, severe bleeding tendency(PT more than 6 seconds above the upper limit of normal with bleeding,or APTT above the upper limit of normal with bleeding, or FIB less than 1.2g/L with bleeding); 5)Patients with terminal stage liver failure and irreversible(Child-Pugh class C); 6)Patients with MAP less than 65mmHg, after standard treatment for spesis shock; 7)Patients with history of allergic reactions to blood purifiers, anticoagulants or cardiopulmonary bypass; 8)Participants who participated in clinical trials of any other drug or medical device within 1 month prior to enrollment; 9)Lactating or pregnant women (except those who have terminated pregnancy and have no need to breastfeed); 10)Patients with any comorbidities that may interfere with the subject's ability to complete the study, including high risk of cerebrovascular events,acute coronary syndrome,or who have been determined by the investigators to be ineligible for participation in this clinical trial, such as current drug abusers, with severe mental, with neurological disorders,or a history of alcoholism that cannot be terminated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Interleukin-6 reduction rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Lipopolysaccharide reduction rate;tumor necrosis factor alpha reduction rate;Interleukin-10 reduction rate;The reduciton rate of IL-6 before and after each adsorption treatment;The reduciton rate of TNF-a before and after each adsorption treatment;The reduciton rate of LPS before and after each adsorption treatment;The reduciton rate of IL-10 before and after each adsorption treatment;PCT reduction rate;LAC reduction rate;SOFA score change from baseline;APACHE II score change from baseline;PaO2/FiO2 value change from baseline;Duration of use of vasoactive drugs;Change in vasoactive drug dependence Index (VDI) from baseline;Total time on mechanical ventilation;The total time and occurence rate of RRT;The hospitalization time in ICU;Total hospitalizaiton time;All-cause death rate in 28d; | — |
Countries
China
Contacts
Public Contactchenzhongqing
NanFang Hospital of Southem Medical University
Outcome results
None listed