Early Endotoxin Burden Reduction With oXiris in Septic Shock Patients Requiring CRRT

Effect of the oXiris Hemofilter on Early Endotoxin Burden in Patients With Septic Shock Requiring Continuous Renal Replacement Therapy: A Single-Center, Prospective, Single-Arm Clinical Trial

The goal of this clinical trial is to learn whether continuous renal replacement therapy (CRRT) using the oXiris filter can lower the amount of endotoxin in the blood of adults with septic shock who need CRRT. Septic shock is a life-threatening condition caused by infection and severe organ dysfunction. CRRT is a form of continuous blood purification used to support the kidneys and manage fluid and waste products. The oXiris filter is designed to provide CRRT while also removing endotoxin and inflammatory substances from the blood.

The main questions this study aims to answer are:

Does 24 hours of CRRT with the oXiris filter lower blood endotoxin levels compared with levels before treatment? What changes occur in inflammation, organ function, and the need for medicines that raise blood pressure? What medical problems or treatment-related complications occur during the study?

This is a single-center study with no comparison group. About 13 participants will take part, and all participants will receive CRRT with the oXiris filter for a planned period of 24 hours. Other treatments for septic shock, including treatment for infection, fluids, medicines to support blood pressure, and other organ support, will be provided according to the hospital's usual care.

Researchers will:

Collect blood samples before and after the 24-hour oXiris treatment to measure endotoxin and markers of inflammation.

Record blood pressure, blood lactate, circulation, organ function, use of blood pressure medicines, and CRRT treatment information.

Continue selected blood tests and clinical assessments during the first 7 days Record any medical problems, including serious medical problems, during the study.

Check whether participants are alive at 28 days and 90 days after enrollment The study may help researchers better understand the biological effects and safety of the oXiris filter and provide information for larger future studies.

Inclusion Criteria:

• Age 18 years or older.
• Diagnosis of septic shock according to Sepsis-3 criteria: sepsis with persistent hypotension requiring vasopressors to maintain a mean arterial pressure of at least 65 mmHg and a blood lactate level greater than 2 mmol/L despite adequate fluid resuscitation.
• Acute kidney injury classified as KDIGO stage 2 or 3.
• A clinical decision by the treating team to initiate continuous renal replacement therapy (CRRT).

Exclusion Criteria:

• The decision to initiate CRRT was made 24 hours or more before enrollment.
• A documented decision to limit life-sustaining treatment or not to pursue invasive treatment.
• Active major bleeding, a major bleeding event within the previous 48 hours, or severe uncorrected bleeding tendency.
• Confirmed or suspected heparin-induced thrombocytopenia, or a known severe allergy to heparin or the filter materials.
• Severe irreversible end-stage organ failure with an expected survival of 48 hours or less.
• Pregnancy or breastfeeding.
• Participation within the previous 6 months in another interventional study that may affect the outcomes of this study.
• Written informed consent not obtained from the participant or legally authorized representative.