Clinical trial NCT03914586: The Membrane Adsorbing OXiris Filter in Septic Patients With AKI
Official title: The OXIRIS Filter in Septic Shock : the Adsorption of Endotoxin and Cytokines Improves the Haemodynamic , the Renal Function , and the Metabolic Response
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Acute Renal Failure
Keywords: Sepsis
Acute Renal Failure
Extra Corporeal Therapy
Lead sponsor: University of Rome Tor Vergata
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2019-04-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with sepsis /septic shock and AKI

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.

Eligibility criteria: 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 )

Primary outcomes:
measure: Hemodynamic Data
timeFrame: At the 24 - 48 hours after starting of the treatment
measure: Renal Data
timeFrame: At the 24 - 48 hours after starting of the treatment
measure: Respiratory Data
timeFrame: At the 24 - 48 hours after starting of the treatment
measure: Calorimetric data
timeFrame: At the 24 - 48 hours after starting of the treatment
Secondary outcomes:
measure: Inflammatory data
timeFrame: At the 24 - 48 hours after starting of the treatment
measure: Coagulation data
timeFrame: At the 24 - 48 hours after starting of the treatment
measure: Cytokines Data
timeFrame: At the 24 - 48 hours after starting of the treatment
measure: Cytokines data
timeFrame: At the 24 - 48 hours after starting of the treatment
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Franco Turani
state: RM
Study officials:
References:
citation: Malard B, Lambert C, Kellum JA. In vitro comparison of the adsorption of inflammatory mediators by blood purification devices. Intensive Care Med Exp. 2018 May 4;6(1):12. doi: 10.1186/s40635-018-0177-2.
citation: Turani F, Barchetta R, Falco M, Busatti S, Weltert L. Continuous Renal Replacement Therapy with the Adsorbing Filter oXiris in Septic Patients: A Case Series. Blood Purif. 2019;47 Suppl 3:1-5. doi: 10.1159/000499589. Epub 2019 Apr 12.