Acute Renal Failure, Sepsis
Conditions
Keywords
Sepsis, Acute Renal Failure, Extra Corporeal Therapy
Brief summary
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
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.
Interventions
DEVICEoXiris filter
Continuous Renal Replacement Therapy with oXiris filter
Sponsors
Baxter Healthcare Corporation
FRANCO TURANI
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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 )
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Calorimetric data | At the 24 - 48 hours after starting of the treatment | Changes of VO2 (mL / min) |
| Hemodynamic Data | At the 24 - 48 hours after starting of the treatment | Changes of vasoactive drugs concentration (micr/Kg/min) |
| Renal Data | At the 24 - 48 hours after starting of the treatment | Changes of Urinary Out Put ( mL/ 24 hours) |
| Respiratory Data | At the 24 - 48 hours after starting of the treatment | Changes of P/F ratio |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory data | At the 24 - 48 hours after starting of the treatment | Changes of Endotoxin ( EAA measurement ) |
| Coagulation data | At the 24 - 48 hours after starting of the treatment | Changes of the PAI-1 ( ng /mL) |
| Cytokines Data | At the 24 - 48 hours after starting of the treatment | IL 6 (pg/mL) |
| Cytokines data | At the 24 - 48 hours after starting of the treatment | IL 10 (pg/mL) |
Countries
Italy
Outcome results
None listed