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

NCT07569406 | Completed

• 1 other identifier: OXIRIS
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Septic Shock; Acute Kidney Injury

Keywords

Oxiris; Renal Replacement Therapy; Continuous Renal Replacement Therapy; Hemofilter; Cytokine Adsorption; Endotoxin Removal; Intensive Care Unit

Outcome Measures

Primary Outcomes (1)

• 28-day all-cause mortality

  All-cause mortality within 28 days from the initiation of renal replacement therapy.

  Up to 28 days

Secondary Outcomes (4)

• ICU length of stay

  From ICU admission to ICU discharge, assessed up to 28 days

• Renal recovery

  Assessed at hospital discharge, up to 90 days

• Duration of renal replacement therapy

  From initiation to discontinuation of RRT, assessed up to 28 days

• In-hospital mortality

  From hospital admission to discharge, assessed up to 90 days

Study Arms (2)

Oxiris Group

Patients with septic shock requiring renal replacement therapy treated with the Oxiris filter.

Device: Oxiris filter

Standard Filter Group

Patients with septic shock requiring renal replacement therapy treated with standard hemofilters.

Device: Standard Hemofilter

Interventions

Oxiris filter DEVICE

Hemofilter used for renal replacement therapy with cytokine and endotoxin adsorption properties.

Oxiris Group

Standard Hemofilter DEVICE

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.

Standard Filter Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead

Study Sites (1)

Clínica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Location

MeSH Terms

Conditions

Shock, Septic; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: May 6, 2026
• Study Start: January 1, 2012
• Primary Completion: July 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)