The Membrane Adsorbing OXiris Filter in Septic Patients With AKI

Study Overview
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Brief Summary
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Patients with Sepsis / Septic Shock and AKI are submitted to Continuous Renal Replacement Therapy with the oXiris filter . The pro- inflammatory mediators , the endotoxin , interleukin 10 , the main cardiorespiratory indices and renal parameters are evaluated at the entry of the study and at the end of the treatment.

Detailed Description
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Patients with a diagnosis of sepsis or septic shock Gram + , Gram - and acute renal failure All patients are submitted to Continuous Renal Replacement Therapy with the treated heparin-coated membrane (oXiris;Baxter ); Citrate Anticoagulation or Heparin with thromboelasthograpy monitoring . Hemodynamic monitoring with dynamic parameters ( Cardiac Index ,Stroke Volume Variation , Pulse Pressure Variation ) and Echocardiography Indirect Calorimetry ( before Continuous Renal Replacement Therapy and after 1 hour stopping Continuous Renal Replacement Therapy ) Laboratory: white blood cell, creatinine, procalcitonin, Interleukin -6, Interleukin -10, Endotoxin , Lactate, diuresis, tromboelastography (post filter and arterial sample ) and dosage of Plasminogen Activator Inhibitor -1 at the same sites.

Official Title
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The OXIRIS Filter in Septic Shock : the Adsorption of Endotoxin and Cytokines Improves the Haemodynamic , the Renal Function , and the Metabolic Response

Conditions
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Sepsis, Acute Renal Failure

Intervention / Treatment
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* Device: oXiris filter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:- Age <18 years 75 years > Diagnosis of sepsis or septic shock (Sepsis III) Mechanical Ventilation or non Invasive ventilation with PaO2 /FIO2 < 200. Renal failure ( AKI ≥ 1) Endotoxin ( EAA ) : EAA ≥ 0.6 -0.9 > or IL6 > 150 pg/mL Exclusion Criteria: Pregnancy; Age < 18 years 75> Chronic Renal failure or previous CRRT Immunological disease or immunosuppressive drugs or EAA < 0.6 with IL 6 in the normal range. CGS < 8 due to hemorrhagic or ischemic event. ECMO v-v or a-v or ECCO2 removal. No resolution of the surgical source of infection Terminal condition Any contraindication to heparin and other anticoagulant. Other pathological conditions in which the oXiris filter is not indicated and other therapeutic options are required. (eg . Hepatic failure , Cardiac failure )

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Septic patients with AKI<br>Patients with sepsis /septic shock ( Sepsis III ) and AKI submitted to Continuous Renal Replacement Therapy with the adsorbing membrane oXiris. | Device: oXiris filter<br>* Continuous Renal Replacement Therapy with oXiris filter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemodynamic Data | Changes of vasoactive drugs concentration (micr/Kg/min) | At the 24 - 48 hours after starting of the treatment | 
| Renal Data | Changes of Urinary Out Put ( mL/ 24 hours) | At the 24 - 48 hours after starting of the treatment | 
| Respiratory Data | Changes of P/F ratio | At the 24 - 48 hours after starting of the treatment | 
| Calorimetric data | Changes of VO2 (mL / min) | At the 24 - 48 hours after starting of the treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory data | Changes of Endotoxin ( EAA measurement ) | At the 24 - 48 hours after starting of the treatment | 
| Coagulation data | Changes of the PAI-1 ( ng /mL) | At the 24 - 48 hours after starting of the treatment | 
| Cytokines Data | IL 6 (pg/mL) | At the 24 - 48 hours after starting of the treatment | 
| Cytokines data | IL 10 (pg/mL) | At the 24 - 48 hours after starting of the treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sepsis, Acute Renal Failure, Extra Corporeal Therapy