The Membrane Adsorbing OXiris Filter in Septic Patients With AKI

Sepsis Clinical Trial

— MOSAKI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03914586
• Other study ID #: 418/CE Lazio 1
• Status: Recruiting
• Start date: January 10, 2019
• Est. completion date: July 30, 2020

Study information

• Verified date: April 2019
• Source: University of Rome Tor Vergata
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 30, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 )

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Renal Failure
• Renal Insufficiency
• Sepsis

Intervention

Device:
• oXiris filter
Continuous Renal Replacement Therapy with oXiris filter

Locations

Country	Name	City	State
Italy	Franco Turani	Rome	RM

Sponsors (2)

Lead Sponsor	Collaborator
FRANCO TURANI	Baxter Healthcare Corporation

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemodynamic Data	Changes of vasoactive drugs concentration (micr/Kg/min)	At the 24 - 48 hours after starting of the treatment
Primary	Renal Data	Changes of Urinary Out Put ( mL/ 24 hours)	At the 24 - 48 hours after starting of the treatment
Primary	Respiratory Data	Changes of P/F ratio	At the 24 - 48 hours after starting of the treatment
Primary	Calorimetric data	Changes of VO2 (mL / min)	At the 24 - 48 hours after starting of the treatment
Secondary	Inflammatory data	Changes of Endotoxin ( EAA measurement )	At the 24 - 48 hours after starting of the treatment
Secondary	Coagulation data	Changes of the PAI-1 ( ng /mL)	At the 24 - 48 hours after starting of the treatment
Secondary	Cytokines Data	IL 6 (pg/mL)	At the 24 - 48 hours after starting of the treatment
Secondary	Cytokines data	IL 10 (pg/mL)	At the 24 - 48 hours after starting of the treatment