Hemodynamic Stability in Septic Shock Patients Undergoing Continuous Renal Replacement Therapy With oXiris Membrane
South Korea98 participantsStarted 2024-01-01
Plain-language summary
The new adsorbing membrane for continuous renal replacement therapy (CRRT), oXiris, can reduce plasma cytokines and endotoxins in septic shock patients with severe acute kidney injury, compared with standard membranes. However, its hemodynamic stability or benefits have not been thoroughly evaluated although this is reasonable.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged ≥ 18 years
* Sepsis related acute kidney injury requiring continuous renal replacement therapy
Exclusion Criteria:
• No monitoring of blood pressure and ECG
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1My loved one has sepsis-related acute kidney injury and needs continuous renal replacement therapy — is the oXiris membrane being studied here something their care team is already considering, and how does it differ from the standard filter they'd normally use?
2Since this trial is tracking all-cause mortality and serious cardiac events like ventricular tachycardia and dangerous drops in blood pressure during dialysis, what does that tell us about the known risks of this treatment approach, and how would those risks be monitored in real time?
3This trial is listed as 'Phase NA,' which I understand may mean it's more of an observational or device study rather than a drug trial — can you explain what that means for how much is already known about the oXiris membrane's safety and benefit in septic shock patients?
4Given how critically ill someone has to be to even be in this situation, how would participating in this trial actually change the day-to-day care my family member receives in the ICU, and are there any additional procedures or monitoring involved?
5Would my loved one be better served by the standard-of-care renal replacement therapy approach right now, or is there a genuine clinical reason to consider this trial — and what factors would help you make that recommendation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of all-cause mortality
Timeframe: 28 days
2
Occurrence rates of ventricular tachycardia, intradialytic hypotension