Septic ShockNCT07569406
Use of Oxiris Filter in Septic Shock Patients Requiring Renal Replacement Therapy: A Retrospective Cohort Study
An observational study of Septic Shock and Acute Kidney Injury, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock, Acute Kidney Injury
- What is being tested?
- Oxiris filter and Standard Hemofilter
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2012to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill adult patients admitted to an intensive care unit with septic shock and acute kidney injury requiring renal replacement therapy.
Who may be able to join
- 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
Who cannot join
- Patients under 18 years of age
- Chronic dialysis prior to ICU admission
- Missing key clinical data
- Patients not meeting criteria for septic shock
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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.
- Conditions
- Septic Shock, Acute Kidney Injury
- Being tested
- Oxiris filter, Standard Hemofilter
- Keywords
- Oxiris, Renal Replacement Therapy, Continuous Renal Replacement Therapy, Hemofilter, Cytokine Adsorption, Endotoxin Removal, Intensive Care Unit
- Medical subject headings
- Shock, Septic, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxiris filterDevice
Hemofilter used for renal replacement therapy with cytokine and endotoxin adsorption properties.
Standard HemofilterDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Oxiris Group | Patients with septic shock requiring renal replacement therapy treated with the Oxiris filter. Receives: Device: Oxiris filter | |
| Standard Filter Group | Patients with septic shock requiring renal replacement therapy treated with standard hemofilters. Receives: Device: Standard Hemofilter |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day all-cause mortality
All-cause mortality within 28 days from the initiation of renal replacement therapy.
Measured: Up to 28 days
Secondary outcomes (4)
ICU length of stay
Length of stay in the intensive care unit measured in days.
Measured: From ICU admission to ICU discharge, assessed up to 28 days
Renal recovery
Recovery of kidney function defined as independence from renal replacement therapy at discharge.
Measured: Assessed at hospital discharge, up to 90 days
Duration of renal replacement therapy
Total duration of renal replacement therapy during ICU stay, measured in days.
Measured: From initiation to discontinuation of RRT, assessed up to 28 days
In-hospital mortality
All-cause mortality during hospital stay.
Measured: From hospital admission to discharge, assessed up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start1 Jan 2012
- Primary completion31 Jul 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07569406
- Sponsor's protocol ID
- OXIRIS
- Status last verified
- Apr 2026
- First submitted
- 20 Apr 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07569406
- Acronym / sponsor ID
- OXIRIS
- Conditions
- Septic Shock, Acute Kidney Injury
- Keywords
- Oxiris, Renal Replacement Therapy, Continuous Renal Replacement Therapy, Hemofilter, Cytokine Adsorption, Endotoxin Removal, Intensive Care Unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxiris Group | – | Device: Oxiris filterPatients with septic shock requiring renal replacement therapy treated with the Oxiris filter. |
| Standard Filter Group | – | Device: Standard HemofilterPatients with septic shock requiring renal replacement therapy treated with standard hemofilters. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill adult patients admitted to an intensive care unit with septic shock and acute kidney injury requiring renal replacement therapy.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Patients under 18 years of age
- Chronic dialysis prior to ICU admission
- Missing key clinical data
- Patients not meeting criteria for septic shock
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxiris filterHemofilter used for renal replacement therapy with cytokine and endotoxin adsorption properties. | Device | Oxiris Group |
| Standard HemofilterStandard 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. | Device | Standard Filter Group |
Primary outcome
28-day all-cause mortality
Time frame: Up to 28 days
All-cause mortality within 28 days from the initiation of renal replacement therapy.
4 secondary outcomes
ICU length of stay
Time frame: From ICU admission to ICU discharge, assessed up to 28 days
Renal recovery
Time frame: 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
In-hospital mortality
Time frame: From hospital admission to discharge, assessed up to 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
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Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Shock and Acute Kidney Injury, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day all-cause mortality (time frame: Up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.