The Membrane Adsorbing OXiris Filter in Septic Patients With AKI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-10

Study Completion Date

2020-07-30

Brief Summary

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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.

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Detailed Description

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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

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Sepsis Acute Renal Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Septic patients with AKI

Patients with sepsis /septic shock ( Sepsis III ) and AKI submitted to Continuous Renal Replacement Therapy with the adsorbing membrane oXiris.

oXiris filter

Intervention Type DEVICE

Continuous Renal Replacement Therapy with oXiris filter

Interventions

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oXiris filter

Continuous Renal Replacement Therapy with oXiris filter

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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 )

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No