Pharmacokinetics Vancomycin CVVHDF with OXiris Membrane

Not Applicable

Recruiting

• Conditions: AKI - Acute Kidney Injury
• Interventions: Drug: Vancomycin

• Registration Number: NCT06543940
• Lead Sponsor: Mahidol University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-07-26
• Study First Submitted QC: 2024-08-07
• Study First Posted: 2024-08-09
• Study Start: 2024-09-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-23
• Last Update Posted: 2025-01-24
• Primary Completion: 2025-08-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 8

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
AUC of vancomycin	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 Outcome Measures

Name	Time	Method
To determine the elimination rate constant (Ke) of vancomycin	1 years	calculated Ke of vancomycin in these patient by phoenix winnonlin software.
To determine the Cmax of vancomycin	1 year	calculated Cmax of vancomycin in these patient by phoenix winnonlin software.
To determine the volume of distribution (Vd) of vancomycin	1 years	calculated Vd of vancomycin in these patient by phoenix winnonlin software.
30-day mortality rate	30 day after intervention period	monitor mortality rate at 30 days after received maintenance dose
percentage of patients who, receiving AUC/MIC ratio within the range of 400 to 600 mg*h/L.	1 years	calculate percent sample who AUC with in target by number sample in target divide to total population.
incidence of adverse effects of vancomycin	1 years	record the incidence of adverse effects during the intervention period.
renal recovery rate at 30 days	30 day after intervention period	monitor renal replacement therapy status at 30 days after received maintenance dose
To determine the half life of vancomycin	1 years	calculated half life of vancomycin in these patient by phoenix winnonlin software.

Trial Locations

Locations (1)

Facullty of Pharmacy Mahidol University; 🇹🇭 Bangkok, Payathi, Thailand