NCT03914586

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 16, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2020

Completed
Last Updated

May 2, 2019

Status Verified

April 1, 2019

Enrollment Period

12 months

First QC Date

April 11, 2019

Last Update Submit

April 30, 2019

Conditions

SepsisAcute Renal Failure

Keywords

SepsisAcute Renal FailureExtra Corporeal Therapy

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (4)

  • Inflammatory data

    At the 24 - 48 hours after starting of the treatment

  • Coagulation data

    At the 24 - 48 hours after starting of the treatment

  • Cytokines Data

    At the 24 - 48 hours after starting of the treatment

  • Cytokines data

    At the 24 - 48 hours after starting of the treatment

Study Arms (1)

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

Interventions

oXiris filterDEVICE

Continuous Renal Replacement Therapy with oXiris filter

Septic patients with AKI

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with sepsis /septic shock and AKI

You may qualify if:

  • 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

You may not qualify if:

  • 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 )

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Franco Turani

Rome, RM, 00152, Italy

RECRUITING

Related 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.

    PMID: 29728790BACKGROUND

  • 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.

    PMID: 30982024BACKGROUND

MeSH Terms

Conditions

SepsisAcute Kidney Injury

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Adjunt Professor of Anesthesia and Intensive Care

Study Record Dates

First Submitted

April 11, 2019

First Posted

April 16, 2019

Study Start

January 10, 2019

Primary Completion

December 30, 2019

Study Completion

July 30, 2020

Last Updated

May 2, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)