Pharmacokinetics Vancomycin CVVHDF with OXiris Membrane

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2025-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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AKI - Acute Kidney Injury

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Vancomycin

administration with vancomycin 7.5 to 10 mg/kg IV q 12 hours in patient received CRRT with oXiris membrane

Group Type EXPERIMENTAL

Vancomycin

Intervention Type DRUG

vancomycin dose is 7.5 to 10 mg/kg

Interventions

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Vancomycin

vancomycin dose is 7.5 to 10 mg/kg

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No