Oxiris in Septic AKI

Impact of Oxiris on Endothelial Cell Dysfunction and Renal Recovery in Patients With Septic Acute Kidney Injury

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sepsis-associated AKI
• Intervention / Treatment: Device: Oxiris; Procedure: Standard CRRT

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Seoul
    • Seoul, Seoul, South Korea, 06351
      • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oxiris	Device: Oxiris; Patients with sepsis and acute kidney injury will be divided into CRRT with Oxiris group and standard CRRT group.
Active Comparator: Standard CRRT	Procedure: Standard CRRT; Patients with sepsis and acute kidney injury will be divided into CRRT with Oxiris group and standard CRRT group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tube formation analysis of iPSC-ECs treated with patient's plasma	Tube formation analysis will be performed on iPSC-ECs treated with patient plasma collected at three critical time points: baseline, day 3 of treatment, and CRRT discontinuation. iPSC-ECs will be pre-treated with plasma samples for 48 hours, then seeded onto Matrigel-coated plates at 1 × 10⁴ cells/well in 15-well μ-Slide Angiogenesis chambers (Ibidi GmbH). After 16 hours of incubation, capillary network formation will be assessed using a Revolve fluorescence microscope at 10× magnification. Quantitative analysis of angiogenic parameters including total tube length, number of branch points, mesh area, and network connectivity will be performed using automated image analysis software.	baseline, day 3, and at the time of CRRT discontinuation(up to 90 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ROS analyses using CellTiter-Glo 2.0, ROS-Glo H 2 O 2 , and CaspaseGlo 3/7 (Promega, Madison, WI)	Assays will be performed following the manufacturer's instruction and the luminescence signal was recorded on the GloMax-Multi detection system (Promega). Cells in the original sample plate will be kept for measuring the total cell number by calcein-AM (Thermo Fisher Scientific) to allow normalization.	baseline, day 3, and at the time of CRRT discontinuation(up to 90 days))

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): June 16, 2026
• Primary Completion (Estimated): March 9, 2028
• Study Completion (Estimated): March 9, 2029

Study Registration Dates

• First Submitted: March 3, 2026
• First Submitted That Met QC Criteria: June 7, 2026
• First Posted (Actual): June 11, 2026

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 7, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: SMC IRB 2025-11-137

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No