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Search / Trial NCT03914586

The Membrane Adsorbing OXiris Filter in Septic Patients With AKI

Launched by FRANCO TURANI · Apr 12, 2019

Trial Information

Current as of July 21, 2025

Unknown status

Keywords

Sepsis Acute Renal Failure Extra Corporeal Therapy

ClinConnect Summary

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 cel...

Gender

ALL

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 )

About Franco Turani

Franco Turani is a distinguished clinical trial sponsor renowned for its commitment to advancing medical research and improving patient outcomes. With a focus on innovative therapies and evidence-based practices, the organization collaborates with leading healthcare institutions and researchers to conduct rigorous clinical studies across various therapeutic areas. Franco Turani prioritizes ethical standards and regulatory compliance, ensuring the highest quality of data and patient safety throughout the trial process. By fostering a culture of collaboration and scientific excellence, Franco Turani aims to contribute significantly to the evolution of healthcare and the development of groundbreaking treatments.

Locations

Rome, Rm, Italy

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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