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Pharmacokinetics Vancomycin CVVHDF with OXiris Membrane

ConditionAKI - Acute Kidney Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMahidol University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Single group

Treatments tested in this trial

  • Vancomycin

    Drug

    vancomycin dose is 7.5 to 10 mg/kg

Treatment groups

8 Participants
are divided into 1 treatment group
Group A: VancomycinExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

AUC of 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)

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

Secondary outcomes

1

To determine the Cmax of vancomycin

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

Time frame
1 year
2

30-day mortality rate

monitor mortality rate at 30 days after received maintenance dose

Time frame
30 day after intervention period
3

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

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

Time frame
1 years
4

incidence of adverse effects of vancomycin

record the incidence of adverse effects during the intervention period.

Time frame
1 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mahidol University

Lead sponsor

Source ClinicalTrials.gov
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