Oxiris in Septic AKI

NCT07641660 | Not Yet Recruiting

• 1 other identifier: SMC IRB 2025-11-137
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sepsis-associated AKI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• ROS analyses using CellTiter-Glo 2.0, ROS-Glo H 2 O 2 , and CaspaseGlo 3/7 (Promega, Madison, WI)

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

Study Arms (2)

Oxiris

EXPERIMENTAL

Device: Oxiris

Standard CRRT

ACTIVE COMPARATOR

Procedure: Standard CRRT

Interventions

Standard CRRT PROCEDURE

Patients with sepsis and acute kidney injury will be divided into CRRT with Oxiris group and standard CRRT group.

Standard CRRT

Oxiris DEVICE

Patients with sepsis and acute kidney injury will be divided into CRRT with Oxiris group and standard CRRT group.

Oxiris

Eligibility Criteria

• Age: 19 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with AKI, aged ≥ 19 years old
• Relevant disease states: sepsis-associated AKI

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, Seoul, 06351, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: June 11, 2026
• Study Start (Estimated): June 16, 2026
• Primary Completion (Estimated): March 9, 2028
• Study Completion (Estimated): March 9, 2029
• Last Updated: June 11, 2026

Record last verified: 2026-06

Locations

KR (1)