Pharmacokinetics Vancomycin CVVHDF with OXiris Membrane

January 23, 2025 updated by: Chidtawan Hirunsomboon, Mahidol University

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Thailand
    • Payathi
      • Bangkok, Payathi, Thailand, 10400
        • Recruiting
        • Facullty of Pharmacy Mahidol University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vancomycin
administration with vancomycin 7.5 to 10 mg/kg IV q 12 hours in patient received CRRT with oXiris membrane
Drug: Vancomycin
vancomycin dose is 7.5 to 10 mg/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
at 0 pre-dose, 2,3,4,5,6,8 and 12 hours after intervention vancomycin

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the Cmax of vancomycin
Time Frame: 1 year
calculated Cmax of vancomycin in these patient by phoenix winnonlin software.
1 year
30-day mortality rate
Time Frame: 30 day after intervention period
monitor mortality rate at 30 days after received maintenance dose
30 day after intervention period
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.
1 years
incidence of adverse effects of vancomycin
Time Frame: 1 years
record the incidence of adverse effects during the intervention period.
1 years
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
30 day after intervention period
To determine the elimination rate constant (Ke) of vancomycin
Time Frame: 1 years
calculated Ke of vancomycin in these patient by phoenix winnonlin software.
1 years
To determine the volume of distribution (Vd) of vancomycin
Time Frame: 1 years
calculated Vd of vancomycin in these patient by phoenix winnonlin software.
1 years
To determine the half life of vancomycin
Time Frame: 1 years
calculated half life of vancomycin in these patient by phoenix winnonlin software.
1 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2024

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

July 26, 2024

First Submitted That Met QC Criteria

August 7, 2024

First Posted (Actual)

August 9, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 23, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUPY00001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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