Septic Shock
Conditions
Interventions
oXiris filter group:Blood purification by oXiris filter plus standard medical care
Sponsors
Department of Critical Care Medicine, Ruijin Hospital North, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Sign the informed consent form (the person without the ability to sign will be signed by the entrusted person) and promise to abide by the research procedures and cooperate in the implementation of the whole process of research. 2. Age >= 18 and = 30 mL/kg crystalloid solution), norepinephrine >= 0.3µg/kg/min are still required (or other vasopressor in equivalent conversion) to maintain MAP at 65mmHg.
Exclusion criteria
Exclusion criteria: 1. Inability to obtain an informed consent from the subject, family member or an authorized surrogate 2. Lack of commitment for full medical support; 3. Subject has end stage renal disease and requires chronic dialysisor end stage liver disease; 4. There is clinical support for non-septic shock such as: a. Acute pulmonary embolus b. Transfusion reaction c. Severe congestive heart failure (e.g. NYHA Class IV, ejection fraction < 35%) 5. Subject has had chest compressions as part of CPR this hospitalization without immediate return to communicative state; 6. Subject has had an acute myocardial infarction (AMI) within the past 4 weeks; 7. Subject has uncontrolled hemorrhage in the past 24 hours, unable to receive anticoagulation therapy; 8. Subject has severe granulocytopenia (leukocyte count less than 500 cells/mm3) or severe thrombocytopenia (platelet count less than 20,000 cells/mm3); 9. HIV infection; 10. Body weight < 35 kg; 11. Subject is currently enrolled in an investigational device trial; 12. Known hypersensitivity to oXiris filter and sensitivity or allergy to heparin or has a history of heparin associated thrombocytopenia (H.I.T.); 13. Pregnant and lactant women; 14. Severe cardiopulmonary disease requires ECMO support; 15. CRRT cannot be implemented within 6 hours after being included in the study; 16. Long-term immunosuppressive treatment or autoimmune disease; 17. Estimated survival time in ICU < 48 hours; 18. Subject has a screening SOFA score <= 2.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mortality at 28 days post-start of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| the mean number of days spent in ICU;the mean hospitalization expenses in ICU;Changes in hemodynamic parameters from Baseline to 72 hours;Changes in the dosing of norepinephrine from Baseline to 72 hours;Changes in renal function(urine volume (ml/hr) and creatinine levels from Baseline to 72 hours);Changes in organ status using elements of the SOFA (Sequential Organ Failure Assessment) score from Baseline to 72 hours;Number of days the subject is alive and free of the need for renal replacement therapy;Number of days the subject is alive and free of the need for Mechanical Ventilation;Number of days the subject is alive and free of the need for Vasopressors;Changes in plasma EAA values from Baseline to 72 hours;Changes in plasma cytokine( TNF-a,IL-6,IL-1ß,IFN-? and IL-10)values from Baseline to 72 hours;Changes in plasma vascular endothelial barrier-related indicators (syndecan-1, E-selectin, Ang-2, VE-cadherin, claudin-5) from Baseline to 72 hours;Changes in plasma coagulation activation and functional indicators (TF, antithrombin-III, ADAMTS13, vWF:Ag, PT, INR, APTT, D-Dimer, Fg) from Baseline to 72 hours;Changes in immune cells of the PBMC from Baseline to 72 hours; | — |
Countries
China
Contacts
Public ContactDechang Chen
Department of Critical Care Medicine, Ruijin Hospital North, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed