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

Recruiting

• Conditions: Acute Kidney Injury Due to Sepsis
• Interventions: Device: oXiris membrane; Device: Polysulfone membrane

• Registration Number: NCT05575024
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2022-10-05
• Study First Submitted QC: 2022-10-08
• Study First Posted: 2022-10-12
• Study Start: 2024-01-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-15
• Primary Completion: 2026-06-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

• Aged ≥ 18 years
• Sepsis related acute kidney injury requiring continuous renal replacement therapy

Exclusion Criteria

• No monitoring of blood pressure and ECG

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Septic AKI	oXiris membrane	Patients with septic acute kidney injury requiring continuous renal replacement therapy
Septic AKI	Polysulfone membrane	Patients with septic acute kidney injury requiring continuous renal replacement therapy

Primary Outcome Measures

Name	Time	Method
Rate of all-cause mortality	28 days	Risk of all-cause mortality
Occurrence rates of ventricular tachycardia, intradialytic hypotension	28 days	Risk of ventricular tachycardia, intradialytic hypotension

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of