A Multiple Centre, Cohort Study of New CRRT Membranes oXiris for Patients With Septic Shock

Study Overview
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Brief Summary
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The objectives of this study are to determine whether Continuous Renal Replacement Therapy (CRRT) with oXiris in patients with septic shock would improve clinical outcomes such as the sepsis-related organ failure assessment (SOFA) , hemodynamic, mortality compared CRRT with conventional membrane.

Detailed Description
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Sepsis is the leading cause of death in ICU, resulting in multi-organ failure in critically ill patients. Patients with septic shock combined sepsis-associated Acute kidney injury (AKI)have even poorer outcome. Endotoxin activity, inflammation and immune dysfunction, have been consider relevant to their pathogenesis of sepsis. High levels of Inflammation are associated with worse clinical outcomes. However, all studies of anti-inflammation treatment in sepsis patient are failed and anti-inflammation treatment of sepsis still remains controversial. oXiris is a new filter with adsorptive membrane, which removes endotoxin and inflammatory mediator from plasma. But current evidence of oXiris is limited, and only some small sample studies have proved that it can improve the haemodynamics and the sepsis-related organ failure assessment(SOFA) score. Our hypothesis was that oXiris would be associated with better clinical outcomes, such as decreased SOFA score, improved survival rate, better hemodynamic, and improved of organ function.

Official Title
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A Multiple Centre, Cohort Study of New Continuous Renal Replacement Therapy (CRRT) Membranes oXiris for Patients With Septic Shock

Conditions
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Acute Kidney Injury Due to Sepsis (Disorder)

Intervention / Treatment
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* Device: Continuous renal replacement therapy with oXiris


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >18 Years Treated by CRRT using oXiris or conventional membrane SOFA cardiovascular Score ≥ 3 Septic shock due to abdominal or pneumonia( Gram-negative bacterial infection or suspected GNB infection) Written informed consent Exclusion Criteria: Chronic Kidney Disease Renal replacement therapy (RRT) in the last 30 days Pregnancy Immunosuppressive treatment or steroids (prednisone > 0.5 mg/kg/day or equivalent). Autoimmune disorder. Transplant receptor. Inclusion in other ongoing studies within the last 30 days. Coexisting illness with a high probability of death

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort study<br>Patients with septic shock undergoing continuous renal replacement therapy | Device: Continuous renal replacement therapy with oXiris<br>* Continuous renal replacement therapy with oXiris in patient with septic shock<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-day mortality | 28-day mortality | 28 days | 
| The Sepsis-related Organ Failure Assessment(SOFA) cardiovascular Scores at 72 hours | The Sepsis-related Organ Failure Assessment(SOFA) cardiovascular Scores at 72 hours(Scores Range 0-4, higher values represent a worse outcome) | 72 hours after Continuous Renal Replacement Therapy initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of Sepsis-related Organ Failure Assessment(SOFA) Score | Changes from baseline to 72 hours in Sepsis-related Organ Failure Assessment(SOFA) Score | 72 hours after Continuous Renal Replacement Therapy initiation | 
| VIS-Norepinephrine dose or equivalent | Norepinephrine dose or equivalent at 72 hours after Continuous Renal Replacement Therapy initiation | 72 hours after Continuous Renal Replacement Therapy initiation | 
| Change of Norepinephrine dose Over Time | Difference of Norepinephrine dose at 72 hours compared with Continuous Renal Replacement Therapy initiation | 72 hours after Continuous Renal Replacement Therapy initiation | 
| Vasopressor-free days | Vasopressor-free days to day 28 | Day 28 | 
| Lactate concentration at 72 hours | Lactate concentration level at 72 hours after Continuous Renal Replacement Therapy initiation initiation | 72 hours after Continuous Renal Replacement Therapy initiation | 
| ICU mortality | All cause mortality in ICU | through study completion, an average of 1 month | 
| mechanical ventilation free days | Total length of mechanical ventilation free days up to to day 28 | Day 28 | 
| Total length of Continuous Renal Replacement Therapy | Total length of Continuous Renal Replacement Therapy to day 28 | Day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Septic shock, AKI, CRRT