NCT03914586

The Membrane Adsorbing OXiris Filter in Septic Patients With AKI

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: FRANCO TURANI · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sepsis
• Acute Renal Failure

Interventions

Type	Name	Description
DEVICE	oXiris filter	Continuous Renal Replacement Therapy with oXiris filter

Timeline

• Start date: 2019-01-10
• Primary completion: 2019-12-30
• Completion: 2020-07-30
• First posted: 2019-04-16
• Last updated: 2019-05-02

Locations

1 site across 1 country: Italy

Regulatory

• FDA-regulated device study