The Membrane Adsorbing OXiris Filter in Septic Patients With AKI (MOSAKI)

FRANCO TURANI

Status: Unknown

Conditions: Acute Renal Failure; Sepsis

Treatments: Device: oXiris filter

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03914586

418/CE Lazio 1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 )

Trial design

100 participants in 1 patient group

Septic patients with AKI

Description:

Patients with sepsis /septic shock ( Sepsis III ) and AKI submitted to Continuous Renal Replacement Therapy with the adsorbing membrane oXiris.

Treatment:

Device: oXiris filter