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

NCT07807410 | Recruiting DMC

• 1 other identifier: SYSKY-2026-525-02
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Septic Shock; Acute Kidney Injury

Keywords

oXiris; CRRT; Endotoxin; Sepsis-Associated Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Blood Endotoxin Level at 24 Hours

  Blood endotoxin concentration will be measured in venous blood using the Limulus amebocyte lysate (LAL) kinetic turbidimetric assay before initiation of oXiris-CRRT and immediately after completion of the planned 24-hour treatment. Change will be calculated as the post-treatment value minus the baseline value. A negative value indicates a reduction in blood endotoxin level.

  Baseline and 24 hours

Secondary Outcomes (3)

• Intensive Care Unit Length of Stay

  From enrollment through ICU discharge or death, assessed up to 90 days

• All-Cause Mortality at Day 28

  Day 28

• All-Cause Mortality at Day 90

  Day 90

Study Arms (1)

oXiris Hemofilter With CRRT

EXPERIMENTAL

Participants will receive CRRT using the oXiris hemofilter in continuous venovenous hemofiltration mode for a planned duration of 24 hours. CRRT settings, anticoagulation, fluid management, antimicrobial treatment, vasopressor support, and other organ support will follow standardized institutional protocols and clinical judgment. Blood samples and clinical assessments will be obtained before treatment and at the end of the 24-hour treatment period to evaluate changes in endotoxin levels, inflammatory markers, hemodynamics, organ function, and treatment-related safety events.

Device: oXiris Hemofilter

Interventions

oXiris Hemofilter DEVICE

The oXiris hemofilter will be integrated into a continuous renal replacement therapy circuit using the Prismaflex system. Continuous venovenous hemofiltration will be performed for a planned duration of 24 hours. The prescribed effluent dose will be 25-30 mL/kg/hour, with a blood flow rate of 100-150 mL/min and a replacement fluid rate of 1,000-1,500 mL/hour. Regional citrate anticoagulation will be preferred unless contraindicated. The filter may be replaced earlier if clotting, increased transmembrane pressure, or other clinical or technical conditions require replacement. Treatment after the planned 24-hour study period will be determined by the treating clinicians according to the participant's clinical condition.

Also known as: oXiris Membrane, Endotoxin- and Cytokine-Adsorbing Hemofilter

oXiris Hemofilter With CRRT

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Shock, Septic; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Zhijie He, MD

CONTACT

+8615923831885; wuyouqixian@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will receive a standardized 24-hour course of continuous renal replacement therapy using the oXiris filter in continuous venovenous hemofiltration mode. Clinical and laboratory outcomes will be assessed at prespecified time points before and after treatment, with follow-up through Day 90.

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: September 8, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: September 8, 2026

Record last verified: 2026-07

Locations

CN (1)