An interventional study of oXiris Hemofilter in Septic Shock and Acute Kidney Injury, sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Not applicable, Interventional, and Treatment
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.
1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.
This study's planned enrollment of 13 is below the median of 79 across 636 interventional studies indexed under Shock, Septic.
Browse Shock, Septic studies →Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University is the lead sponsor of 483 studies on the registry; 283 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
Time frame: Baseline and 24 hours
Intensive Care Unit Length of Stay
The number of days from study enrollment to discharge from the intensive care unit or death in the intensive care unit.
Time frame: From enrollment through ICU discharge or death, assessed up to 90 days
All-Cause Mortality at Day 28
The number and percentage of participants who die from any cause within 28 days after enrollment.
Time frame: Day 28
All-Cause Mortality at Day 90
The number and percentage of participants who die from any cause within 90 days after enrollment.
Time frame: Day 90
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University →