Pharmacokinetics Vancomycin CVVHDF with OXiris Membrane

Last updated: January 23, 2025
Sponsor: Mahidol University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Renal Failure

Kidney Failure

Kidney Disease

Treatment

Vancomycin

Clinical Study ID

NCT06543940
MUPY00001
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 oXirisfilter.

  • who have signed the informed consent document.

Exclusion

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 drawperiod.

  • 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.

Study Design

Total Participants: 8
Treatment Group(s): 1
Primary Treatment: Vancomycin
Phase:
Study Start date:
September 01, 2024
Estimated Completion Date:
December 31, 2025

Study Description

This study monitors the levels of the maintenance dose of vancomycin in patients receiving continuous renal replacement therapy (CRRT) with the CVVHDF mode using the oXiris membrane. Blood samples were drawn from the A-line at the following time points: 0 (predose), 2, 3, 4, 5, 6, 8, and 12 hours after drug administration. The area under the curve (AUC) of the drug was calculated using the Phoenix WinNonlin program. Additionally, we reported the pharmacokinetic profile of this drug in patients with acute kidney injury (AKI) undergoing CRRT with the oXiris membrane.

Connect with a study center

  • Facullty of Pharmacy Mahidol University

    Bangkok, Payathi 10400
    Thailand

    Active - Recruiting

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