Not Yet RecruitingNot Applicable

Oxiris in Septic AKI

South Korea32 participantsStarted 2026-06-16

Plain-language summary

Sepsis is a leading cause of acute kidney injury (AKI) in critically ill patients, with sepsis-associated AKI accounting for approximately 50% of all AKI cases in the intensive care unit. The pathophysiology of septic AKI involves a complex interplay of inflammation, endothelial dysfunction, and microvascular injury, leading to impaired renal perfusion and tubular damage. Despite advances in critical care, septic AKI remains associated with high mortality rates and significant risk of progression to chronic kidney disease. Continuous renal replacement therapy (CRRT) is the standard extracorporeal treatment for AKI in hemodynamically unstable patients. The Oxiris hemofilter (Baxter/Vantive) is a specialized AN69-based membrane with enhanced adsorptive capacity for cytokines and endotoxins due to a polyethyleneimine surface treatment and heparin grafting. While Oxiris has demonstrated the ability to reduce circulating inflammatory mediators in septic patients, its impact on endothelial cell dysfunction and subsequent renal recovery has not been systematically evaluated. This is a single-center, prospective, open-label, exploratory randomized controlled trial comparing CRRT using the Oxiris filter versus CRRT using a standard filter in patients with sepsis-associated AKI at Samsung Medical Center, Seoul, Korea. A total of 30 patients (15 per group) will be enrolled and allocated using stratified randomization based on SOFA score, baseline renal function, and presence of septic shock. Eligible participants are adult patients (aged 19 years or older) diagnosed with sepsis according to Sepsis-3 criteria who develop AKI (KDIGO stage 2 or higher) requiring CRRT initiation. Key exclusion criteria include end-stage kidney disease, expected survival of less than 24 hours, prior CRRT within 72 hours, and contraindications to heparin-based anticoagulation. CRRT will be maintained for a minimum of 72 hours, with Oxiris filters replaced every 24 hours per manufacturer guidelines. The primary endpoints are changes in endothelial cell function assessed using induced pluripotent stem cell-derived endothelial cells (iPSC-ECs) treated with patient plasma collected at three time points: CRRT initiation (baseline), day 3, and CRRT discontinuation. Endothelial function will be evaluated by tube formation assay (total tube length, branch points, mesh area) and reactive oxygen species (ROS) production. This iPSC-EC-based model provides a reproducible and standardized platform to directly assess the biological effects of Oxiris on vascular endothelial integrity under conditions mimicking the pathophysiological environment of septic AKI. Secondary endpoints include 90-day all-cause mortality, renal recovery (defined as dialysis independence at 90 days), changes in hemodynamic parameters (vasopressor requirements, mean arterial pressure), CRRT duration, and serial measurements of blood and urine biomarkers including NGAL, KIM-1, MCP-1, RANTES, and TGF-beta. These biomarkers reflect inflammatory burden, endothelial dysfunction, and renal tubular injury, providing a comprehensive assessment of the therapeutic effects of Oxiris beyond standard cytokine clearance. As this is an exploratory study, all p-values will be interpreted descriptively and results will be used to generate hypotheses and inform the design of future confirmatory trials. The study aims to provide mechanistic insights into whether enhanced cytokine and endotoxin removal by Oxiris translates into measurable improvements in endothelial function and clinical renal outcomes.

Who can participate

Age range

19 Years – 84 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult patients with AKI, aged ≥ 19 years old * Relevant disease states: sepsis-associated AKI Exclusion Criteria: * Age \> 85 years old * Uncontrolled malignancy * End-stage kidney disease * End-stage hepatic failure requiring MARS or liver transplantation * End-stage heart failure requiring extracorporeal membrane oxygenation (ECMO), left ventricular assist device (LVAD), intra-aortic balloon pump (IABP), or heart transplantation

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial isn't recruiting yet — do you know when it's expected to open, and would it even be realistic for me to be considered given how quickly sepsis-associated AKI needs to be treated?
2The primary outcome seems to be a lab-based test looking at how blood vessel cells behave when exposed to my plasma — can you help me understand what that actually tells researchers, and how it connects to my real-world kidney recovery?
3Since this trial doesn't have a standard phase listed, what does that tell us about where it sits in the research process, and does that mean there's less known about safety and benefit compared to a Phase 2 or Phase 3 study?
4Are there existing standard-of-care treatments for sepsis-associated AKI that I should be pursuing right now, and how would participating in something like this fit alongside those treatments?
5Given that I or my loved one may be critically ill with sepsis-related kidney injury, is a trial that appears to be in an early or observational stage the right focus at this moment, or are there other more established options worth prioritizing first?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Tube formation analysis of iPSC-ECs treated with patient's plasma

Timeframe: baseline, day 3, and at the time of CRRT discontinuation(up to 90 days)

Trial details

NCT IDNCT07641660

SponsorSamsung Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-03-09

View on ClinicalTrials.gov More Sepsis-associated AKI trials