NCT05575024

Hemodynamic Stability in Septic Shock Patients Undergoing Continuous Renal Replacement Therapy With oXiris Membrane

Real-time Monitoring of Hemodynamic Stability in Septic Shock Patients Undergoing Continuous Renal Replacement Therapy: Propensity Score-matched Comparison Between oXiris and Polysulfone Membranes

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 98 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The new adsorbing membrane for continuous renal replacement therapy (CRRT), oXiris, can reduce plasma cytokines and endotoxins in septic shock patients with severe acute kidney injury, compared with standard membranes. However, its hemodynamic stability or benefits have not been thoroughly evaluated although this is reasonable.

Detailed description

The new adsorbing membrane for continuous renal replacement therapy (CRRT), oXiris, can reduce plasma cytokines and endotoxins in patients with severe acute kidney injury or sepsis, compared with standard membranes. Based on this benefit, the use of oXiris may confer better outcomes than other membranes. The patient outcomes include cardiovascular, respiratory, renal, and overall survivals, but this information of oXiris are insufficient. Although cytokine and endotoxin removal rates are great in oXiris, the beneficial effects on the hard outcomes are needed to use oXiris in real clinical practice. The inflammatory and cardiovascular systems have intensive crosstalk, and thus if there are remission in inflammatory process, the patients can have hemodynamic stability. Regarding this, the investigators would like to compare the hemodynamic stability between oXiris and other standard membrane such as polysulfone, using our new real-time monitoring registry.

Conditions

• Acute Kidney Injury Due to Sepsis

Interventions

Type	Name	Description
DEVICE	oXiris membrane	Perform continuous renal replacement therapy with oXiris membrane
DEVICE	Polysulfone membrane	Perform continuous renal replacement therapy with polysulfone membrane

Timeline

• Start date: 2024-01-01
• Primary completion: 2026-06-30
• Completion: 2026-12-31
• First posted: 2022-10-12
• Last updated: 2025-05-15

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated device study