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NCT Number: NCT06543940

Pharmacokinetics Vancomycin CVVHDF with OXiris Membrane

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.

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Key information

Conditions

AKI - Acute Kidney Injury Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Facullty of Pharmacy Mahidol University

Bangkok, Payathi, 10400, Thailand

Location status: Recruiting

Location contact

Chidtawan Hirunsomboon

CONTACT

[email protected]

(+66)98-8309558

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vancomycin

Drug

vancomycin dose is 7.5 to 10 mg/kg

Primary outcomes

  1. AUC of vancomycin

    Time frame: at 0 pre-dose, 2,3,4,5,6,8 and 12 hours after intervention vancomycin

    calculated AUC of vancomycin by 8 points of drug level. (at 0 pre-dose, 2,3,4,5,6,8 and 12 hours after administration)

Secondary outcomes

  1. To determine the Cmax of vancomycin

    Time frame: 1 year

    calculated Cmax of vancomycin in these patient by phoenix winnonlin software.

  2. 30-day mortality rate

    Time frame: 30 day after intervention period

    monitor mortality rate at 30 days after received maintenance dose

  3. percentage of patients who, receiving AUC/MIC ratio within the range of 400 to 600 mg*h/L.

    Time frame: 1 years

    calculate percent sample who AUC with in target by number sample in target divide to total population.

  4. incidence of adverse effects of vancomycin

    Time frame: 1 years

    record the incidence of adverse effects during the intervention period.

  5. renal recovery rate at 30 days

    Time frame: 30 day after intervention period

    monitor renal replacement therapy status at 30 days after received maintenance dose

  6. To determine the elimination rate constant (Ke) of vancomycin

    Time frame: 1 years

    calculated Ke of vancomycin in these patient by phoenix winnonlin software.

  7. To determine the volume of distribution (Vd) of vancomycin

    Time frame: 1 years

    calculated Vd of vancomycin in these patient by phoenix winnonlin software.

  8. To determine the half life of vancomycin

    Time frame: 1 years

    calculated half life of vancomycin in these patient by phoenix winnonlin software.

Study contacts

Contact information is provided by the study sponsor or research team.

chidtawan Hirunsomboon, PharmD

CONTACT

[email protected]

+66-988309558

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 9, 2024
Registry last updated
Jan 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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