The Membrane Adsorbing OXiris Filter in Septic Patients With AKI

• Conditions: Acute Renal Failure; Sepsis
• Interventions: Device: oXiris filter

• Registration Number: NCT03914586
• Lead Sponsor: FRANCO TURANI

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.

Study Timeline

• Study Start: 2019-01-10
• Status Verified: 2019-04
• Study First Submitted: 2019-04-11
• Study First Submitted QC: 2019-04-12
• Study First Posted: 2019-04-16
• Last Update Submitted: 2019-04-30
• Last Update Posted: 2019-05-02
• Primary Completion: 2019-12-30
• Study Completion: 2020-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 )

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Septic patients with AKI	oXiris filter	Patients with sepsis /septic shock ( Sepsis III ) and AKI submitted to Continuous Renal Replacement Therapy with the adsorbing membrane oXiris.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Franco Turani; 🇮🇹 Rome, RM, Italy