Use of Oxiris Filter in Septic Shock Patients Requiring Renal Replacement Therapy: A Retrospective Cohort Study

April 28, 2026 updated by: Clinica Universidad de Navarra, Universidad de Navarra

Impact of Oxiris Filter Use on Mortality and Renal Outcomes in Critically Ill Patients With Septic Shock Requiring Renal Replacement Therapy: A Retrospective Cohort Study

Sepsis and septic shock are major causes of mortality in critically ill patients and are frequently associated with acute kidney injury requiring renal replacement therapy. The Oxiris filter is a hemofilter designed to provide both renal support and adsorption of endotoxins and inflammatory mediators. This study aims to evaluate the association between the use of the Oxiris filter and clinical outcomes in critically ill patients with septic shock requiring renal replacement therapy. A retrospective cohort design will be used, including patients admitted to an intensive care unit who received renal replacement therapy. Outcomes such as mortality and renal function will be analyzed and compared between patients treated with Oxiris and those treated with other filters.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Sepsis and septic shock are leading causes of morbidity and mortality in critically ill patients and are commonly associated with acute kidney injury requiring renal replacement therapy (RRT). Extracorporeal blood purification techniques have been proposed as an adjunctive therapy to modulate the host inflammatory response. The Oxiris filter is a modified AN69-based membrane designed to provide renal support while simultaneously adsorbing endotoxins and cytokines.

This retrospective cohort study aims to assess the impact of Oxiris filter use on clinical outcomes in patients with septic shock requiring RRT. The study will include adult patients admitted to an intensive care unit over a defined study period who required RRT due to acute kidney injury in the context of septic shock.

Patients will be categorized according to the type of hemofilter used (Oxiris versus standard filters). The primary outcome will be mortality within a defined follow-up period. Secondary outcomes will include renal recovery, duration of renal replacement therapy, and length of stay in the intensive care unit.

Statistical analyses will be performed to compare outcomes between groups and adjust for potential confounding factors. Appropriate multivariable models will be used to evaluate the association between Oxiris use and clinical outcomes.

Given the retrospective nature of the study, no interventions will be assigned, and all treatments will have been administered according to routine clinical practice.

Study Type

Observational

Enrollment (Actual)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Clinica Universidad de Navarra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Critically ill adult patients admitted to an intensive care unit with septic shock and acute kidney injury requiring renal replacement therapy.

Description

Inclusion Criteria:

  • Adult patients (≥18 years old)
  • Admission to the intensive care unit
  • Diagnosis of septic shock
  • Requirement of renal replacement therapy due to acute kidney injury
  • Treatment with either Oxiris filter or standard hemofilters

Exclusion Criteria:

  • Patients under 18 years of age
  • Chronic dialysis prior to ICU admission
  • Missing key clinical data
  • Patients not meeting criteria for septic shock

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Oxiris Group
Patients with septic shock requiring renal replacement therapy treated with the Oxiris filter.
Device: Oxiris filter
Hemofilter used for renal replacement therapy with cytokine and endotoxin adsorption properties.
Standard Filter Group
Patients with septic shock requiring renal replacement therapy treated with standard hemofilters.
Device: Standard Hemofilter
Standard hemofilters used for continuous renal replacement therapy without specific adsorption properties for endotoxins or cytokines. These filters provide conventional renal support and are used according to routine clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
28-day all-cause mortality
Time Frame: Up to 28 days
All-cause mortality within 28 days from the initiation of renal replacement therapy.
Up to 28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICU length of stay
Time Frame: From ICU admission to ICU discharge, assessed up to 28 days
Length of stay in the intensive care unit measured in days.
From ICU admission to ICU discharge, assessed up to 28 days
Renal recovery
Time Frame: Assessed at hospital discharge, up to 90 days
Recovery of kidney function defined as independence from renal replacement therapy at discharge.
Assessed at hospital discharge, up to 90 days
Duration of renal replacement therapy
Time Frame: From initiation to discontinuation of RRT, assessed up to 28 days
Total duration of renal replacement therapy during ICU stay, measured in days.
From initiation to discontinuation of RRT, assessed up to 28 days
In-hospital mortality
Time Frame: From hospital admission to discharge, assessed up to 90 days
All-cause mortality during hospital stay.
From hospital admission to discharge, assessed up to 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2012

Primary Completion (Actual)

July 31, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

April 20, 2026

First Submitted That Met QC Criteria

April 28, 2026

First Posted (Actual)

May 6, 2026

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OXIRIS

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

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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