Study of Vancomycin Levels in Adults Receiving Continuous Veno-Venous Hemodiafiltration with the OXiris Membrane for Acute Kidney Injury
Led by Mahidol University · Updated on 2025-01-24
8
Participants Needed
1
Research Sites
21 weeks
Total Duration
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
Research Team
C
chidtawan Hirunsomboon, PharmD
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match. Sign up to get personalized trial recommendations delivered to your inbox.
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
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
Similar Trials
Comparing Kidney and Limb NIRS Sensors to Predict Acute Kidney Injury
in Adults Undergoing Cardiac Surgery with Cardiopulmonary Bypass
Evaluating Contrast-Enhanced Ultrasound and Super-Resolution Imaging to Predict Kidney Function After Partial or Radical Nephrectomy in Renal Cell Cancer Patients
Study on Safety and Effectiveness of Citrate Anticoagulation in Continuous Kidney Therapy for Adults with Liver Failure and Severe Shock
Studying Kidney Blood Flow and Inflammation in Adults Over 30 with Severe Infections and Acute Kidney Injury Using PET-CT Scans
Study of Recovery After Acute Kidney Injury Requiring Dialysis with Patient and Doctor Information Sharing
Study of Vancomycin Levels in Adults Receiving Continuous Veno-Venous Hemodiafiltration with the OXiris Membrane for Acute Kidney Injury
A Randomized Double-Blinded Study of Single-Dose Methylprednisolone to Prevent Kidney Injury in Adults Undergoing Elective Cardiac Surgery with Cardiopulmonary Bypass
Study of Kidney Blood Flow Changes and Acute Kidney Injury After Traumatic Injury in ICU Patients
Comparing Safety and Effectiveness of oXiris and M100 Filters in Adults with Pneumonia-Related Acute Kidney Injury Receiving Continuous Renal Replacement Therapy
Have more questions? Get in touch with our team for quick support
Published Research Related To This Trial
Adsorption 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...
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.