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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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
RECRUITING
Guangzhou
Contact Information
Primary
Zhijie He, MD
wuyouqixian@163.com
+8615923831885
Time Frame
Start Date: 2026-08-01
Estimated Completion Date: 2027-08-01
Participants
Target number of participants: 13
Treatments
Experimental: oXiris Hemofilter With CRRT
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.
Related Therapeutic Areas
Sponsors
Leads: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

This content was sourced from clinicaltrials.gov