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NCT Number: NCT07569406

Use of Oxiris Filter in Septic Shock Patients 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clínica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxiris filter

Device

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

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.

Primary outcomes

  1. 28-day all-cause mortality

    Time frame: Up to 28 days

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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. In-hospital mortality

    Time frame: From hospital admission to discharge, assessed up to 90 days

    All-cause mortality during hospital stay.

Sponsors and collaborators

Lead sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2024
Study completion
2024
First posted
May 6, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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