Early Endotoxin Burden Reduction With oXiris in Septic Shock Patients Requiring CRRT
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
oXiris Hemofilter
DeviceThe 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.
Treatment groups
13 Participants
are divided into 1 treatment groupGroup A: oXiris Hemofilter With CRRTExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Baseline and 24 hoursSecondary outcomes
1
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 days2
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 283
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 90Sponsors and contacts
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Source ClinicalTrials.gov