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

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

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.

Study Overview

• Status: Unknown
• Conditions: Sepsis; Acute Renal Failure
• Intervention / Treatment: Device: oXiris filter

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Italy
  • RM
    • Rome, RM, Italy, 00152
      • Recruiting
      • Franco Turani
      • Contact: FRANCO TURANI, MD; Phone Number: 00393484725073; Email: turani.franco44@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with sepsis /septic shock and AKI

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory data	Changes of Endotoxin ( EAA measurement )	At the 24 - 48 hours after starting of the treatment
Coagulation data	Changes of the PAI-1 ( ng /mL)	At the 24 - 48 hours after starting of the treatment
Cytokines Data	IL 6 (pg/mL)	At the 24 - 48 hours after starting of the treatment
Cytokines data	IL 10 (pg/mL)	At the 24 - 48 hours after starting of the treatment

Collaborators and Investigators

• Sponsor: FRANCO TURANI
• Collaborators: Baxter Healthcare Corporation

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2019
• Primary Completion (Anticipated): December 30, 2019
• Study Completion (Anticipated): July 30, 2020

Study Registration Dates

• First Submitted: April 11, 2019
• First Submitted That Met QC Criteria: April 12, 2019
• First Posted (Actual): April 16, 2019

Study Record Updates

• Last Update Posted (Actual): May 2, 2019
• Last Update Submitted That Met QC Criteria: April 30, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Sepsis; Acute Renal Failure; Extra Corporeal Therapy
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: 418/CE Lazio 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes