Loading
Septic Shock / oXiris Hemofilter / Acute Kidney Injury · Interventional Study
ClinicalTrials.gov · September 8, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registry record for a planned single-arm pilot study of the oXiris hemofilter in septic shock patients requiring CRRT. The study is designed to measure change in blood endotoxin level at 24 hours and to collect preliminary safety and biological response data. No results are yet reported; the trial is currently recruiting.
Interventional, Single Group, Open label, Treatment purpose. Septic Shock, Acute Kidney Injury; age from 18 Years. Intervention: oXiris Hemofilter With CRRT. n = 13. 1 site: China.
This is a registry record for a planned single-arm pilot study of the oXiris hemofilter in septic shock patients requiring CRRT. The study is designed to measure change in blood endotoxin level at 24 hours and to collect preliminary safety and biological response data. No results are yet reported; the trial is currently recruiting.
Very small planned sample size (n=13); inadequate to assess clinical benefit, serious adverse events, or mortality. Primary outcome is a surrogate biomarker (endotoxin); clinical efficacy and safety remain to be determined.
Clinicians should recognize this as early-stage exploratory work to assess whether the oXiris filter affects endotoxin levels. Results from this small uncontrolled pilot cannot yet support changes in clinical practice and will require confirmation in larger, controlled trials before any therapeutic claim can be made.
This is a single-center, uncontrolled pilot study with no comparator group and an estimated enrollment of only 13 participants, designed to assess feasibility and biological effect on a surrogate endpoint (endotoxin level) rather than clinical outcomes.
As stated by the source record.
Quoted from the source exactly as published.
Clinicians should recognize this as early-stage exploratory work to assess whether the oXiris filter affects endotoxin levels. Results from this small uncontrolled pilot cannot yet support changes in clinical practice and will require confirmation in larger, controlled trials before any therapeutic claim can be made.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07807410). This is a study registration, not published results. Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 13 participants (ESTIMATED). Conditions: Septic Shock, Acute Kidney Injury. Interventions: DEVICE: oXiris Hemofilter. Primary outcome measures: Change From Baseline in Blood Endotoxin Level at 24 Hours , Baseline and 24 hours. 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.