The use of vancomycin with its therapeutic and adverse effects: a review.
F R Bruniera, F M Ferreira, L R M Saviolli...
https://pubmed.ncbi.nlm.nih.gov/25753888Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06543940
Pharmacokinetics of Vancomycin in Patients Receiving Continuous Veno-Venous Hemodiafiltration (CVVHDF) with the Absorptive OXiris Membrane
Led by Mahidol University · Updated on 2025-01-24
8
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how the antibiotic vancomycin behaves in patients with acute kidney injury (AKI) who are receiving continuous veno-venous hemodiafiltration (CVVHDF) using an oXiris membrane. This membrane is designed to absorb inflammatory substances, and prior lab studies suggest it may reduce vancomycin levels by about 20 percent. However, there is limited data from living patients, so this study aims to measure vancomycin levels to better understand its pharmacokinetics during this treatment. Participants receive vancomycin doses ranging from 7.5 to 10 mg per kilogram of body weight every 12 hours while undergoing CRRT with the oXiris membrane. Blood samples are collected at multiple time points before and after vancomycin dosing, specifically at 0 (before dose), 2, 3, 4, 5, 6, 8, and 12 hours. These samples help calculate the area under the curve (AUC) and other pharmacokinetic parameters to assess how the drug is processed in the body during this therapy. Throughout the study, participants are closely monitored with blood tests to measure vancomycin levels and other key pharmacokinetic markers such as maximum concentration, elimination rate, volume of distribution, and half-life. The study also tracks patient outcomes including mortality, kidney recovery, and any adverse effects related to vancomycin over a one-year period. The total participation duration and follow-up details are aligned with these evaluations to ensure comprehensive data collection.
CONDITIONS
Brief Title
Pharmacokinetics Vancomycin CVVHDF with OXiris Membrane
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- 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
- Signed the informed consent document
You will not qualify if you...
- History of vancomycin allergy
- Expected to die within 24 hours after inclusion in study
- Circuit clotting occurring more than 2 hours during blood draw period
- Treated with extracorporeal membrane oxygenation (ECMO)
- History of kidney transplantation
- Pregnant or breastfeeding women
- Decided to receive palliative care
- On hemodialysis or peritoneal dialysis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Treatment duration depends on clinical need during CRRT
Participants receive vancomycin 7.5 to 10 mg/kg intravenously every 12 hours while undergoing continuous renal replacement therapy (CRRT) with CVVHDF using the oXiris membrane. Blood samples are taken at multiple time points after each vancomycin dose to monitor drug levels.
Blood samples collected at 0 (pre-dose), 2, 3, 4, 5, 6, 8, and 12 hours after vancomycin administration
Follow-up
Duration - Up to 1 year after treatment
Participants are monitored for up to 1 year to assess pharmacokinetic outcomes, adverse effects, renal recovery, and mortality rates after treatment.
Follow-up assessments at 30 days and periodically up to 1 year
Trial Site Locations
Total: 1 location
1
Facullty of Pharmacy Mahidol University
Bangkok, Payathi, Thailand, 10400
Actively Recruiting
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Research Team
C
chidtawan Hirunsomboon, PharmD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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Published Research Related To This Trial
Therapeutic monitoring of vancomycin for serious methicillin-resistant Staphylococcus aureus infections: A revised consensus guideline and review by the American Society of Health-System Pharmacists, the Infectious Diseases Society of America, the Pediatric Infectious Diseases Society, and the Society of Infectious Diseases Pharmacists.
Michael J Rybak, Jennifer Le, Thomas P Lodise...
https://pubmed.ncbi.nlm.nih.gov/32191793Vancomycin pharmacokinetics in critically ill patients receiving continuous venovenous haemodiafiltration.
Megan E DelDot, Jeffrey Lipman, Susan E Tett
https://pubmed.ncbi.nlm.nih.gov/15327585Vancomycin clearance during continuous venovenous haemofiltration in critically ill patients.
Weerachai Chaijamorn, Arnurai Jitsurong, Kamonthip Wiwattanawongsa...
https://pubmed.ncbi.nlm.nih.gov/21636256Adsorption of vancomycin, gentamycin, ciprofloxacin and tygecycline on the filters in continuous renal replacement therapy circuits: in full blood in vitro study.
Dariusz Onichimowski, Krzysztof Nosek, Hubert Ziółkowski...
https://pubmed.ncbi.nlm.nih.gov/33033945