Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06543940

Pharmacokinetics of Vancomycin in Patients Receiving Continuous Veno-Venous Hemodiafiltration with the Absorptive OXiris Membrane

Led by Mahidol University · Updated on 2025-01-24

8

Participants Needed

1

Research Sites

69 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying how vancomycin behaves in the body of patients with acute kidney injury (AKI) who are receiving continuous renal replacement therapy (CRRT) using continuous veno-venous hemodiafiltration (CVVHDF) with the oXiris membrane. The oXiris membrane is designed to absorb inflammatory substances, and previous studies suggest it may reduce vancomycin levels by about 20%. Since there is limited data on this effect in living patients, this study aims to measure vancomycin levels to understand its pharmacokinetics when using this membrane. Participants receive vancomycin doses ranging from 7.5 to 10 mg/kg while undergoing CRRT with the oXiris membrane. Blood samples are collected from an arterial line before the dose and at multiple time points afterward (2, 3, 4, 5, 6, 8, and 12 hours) to assess how the drug is processed over time. The area under the curve (AUC) for vancomycin concentration is calculated to evaluate drug exposure and behavior in these patients. During the study, patients are monitored in the intensive care unit and have blood drawn at specified times to track vancomycin levels. Researchers analyze these samples to report the drug’s pharmacokinetic profile in patients with AKI receiving CRRT with the oXiris membrane. The study focuses on safety and detailed drug monitoring to better understand vancomycin dosing in this setting.

CONDITIONS

Official Title

Pharmacokinetics Vancomycin CVVHDF with OXiris Membrane

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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.
Not Eligible

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 the 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.

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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/32191793

Vancomycin clearance during continuous venovenous haemofiltration in critically ill patients.

Weerachai Chaijamorn, Arnurai Jitsurong, Kamonthip Wiwattanawongsa...

https://pubmed.ncbi.nlm.nih.gov/21636256

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...

https://pubmed.ncbi.nlm.nih.gov/33033945