Reducing Endotoxin Burden in Septic Shock Patients on CRRT with the oXiris Filter

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center, interventional study enrolls about 13 adults with septic shock and acute kidney injury who require CRRT. Participants receive 24 hours of CRRT using the oXiris hemofilter, which is designed to remove endotoxin and inflammatory mediators in addition to supporting kidney function. The study measures changes in endotoxin levels, inflammation, organ function, and vasopressor requirements to assess safety and potential clinical impact. There is no control group for comparison. Enrollment criteria include Sepsis-3 septic shock, KDIGO stage 2–3 AKI, and a plan to initiate CRRT by the treating team.

Why it matters

Who can join: the full rules

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.

Where it's running

• Sun Yat-sen Memorial Hospital, Sun Yat-sen University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Zhijie He, MD
• Email: wuyouqixian@163.com
• Phone: +8615923831885

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.