Pharmacokinetics Vancomycin CVVHDF with OXiris Membrane
Thailand8 participantsStarted 2024-09-01
Plain-language summary
This study is a general pharmacokinetic investigation of vancomycin in patients receiving continuous veno-venous hemodiafiltration (CRRT) with the oXiris membrane. This membrane offers the added benefit of absorbing inflammatory cytokines. In vitro studies show that vancomycin is reduced by around 20 percent in patients using the AN69ST membrane, which is part of the oXiris membrane's structure. However, there is currently a lack of in vivo studies demonstrating the impact of the oXiris membrane on vancomycin levels. Therefore, the hypothesis of this study is that vancomycin is also reduced by absorption in the oXiris membrane. This study measures the levels of vancomycin in these patients to determine the pharmacokinetic parameters.
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:
* Patients aged more than 18 years.
* Admitted to the intensive care unit of Ramathibodi Hospital.
* Under continuous renal replacement therapy (CRRT) with CVVHDF using oXiris filter.
* Received vancomycin at least once after starting CRRT with CVVHDF using oXiris filter.
* who have signed the informed consent document.
Exclusion Criteria:
* Patients with a history of vancomycin allergy.
* Patients expected to die within 24 hours after inclusion in study.
* Patients with circuit clotting occurring more than 2 hours during the blood draw period.
* Patients treated with extracorporeal membrane oxygenation (ECMO).
* Patients with a history of kidney transplantation.
* Pregnant or breastfeeding women.
* Patients who have decided to receive palliative care.
* Patients on hemodialysis or peritoneal dialysis.
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
AUC of vancomycin
Timeframe: at 0 pre-dose, 2,3,4,5,6,8 and 12 hours after intervention vancomycin