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Pharmacokinetics Vancomycin CVVHDF with OXiris Membrane

M

Mahidol University

Status

Enrolling

Conditions

AKI - Acute Kidney Injury

Treatments

Drug: Vancomycin

Study type

Interventional

Funder types

Other

Identifiers

NCT06543940
MUPY00001

Details and patient eligibility

About

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.

Full 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.

Enrollment

8 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

8 participants in 1 patient group

Vancomycin
Experimental group
Description:
administration with vancomycin 7.5 to 10 mg/kg IV q 12 hours in patient received CRRT with oXiris membrane
Treatment:
Drug: Vancomycin

Trial contacts and locations

1

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Central trial contact

chidtawan Hirunsomboon, PharmD

Data sourced from clinicaltrials.gov

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