AKI - Acute Kidney Injury
Conditions
Keywords
vancomycin, CRRT, oXiris membrane
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.
Interventions
DRUGVancomycin
vancomycin dose is 7.5 to 10 mg/kg
Sponsors
Mahidol University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| To determine the Cmax of vancomycin | 1 year | calculated Cmax of vancomycin in these patient by phoenix winnonlin software. |
| 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 volume of distribution (Vd) of vancomycin | 1 years | calculated Vd of vancomycin in these patient by phoenix winnonlin software. |
| To determine the half life of vancomycin | 1 years | calculated half life of vancomycin in these patient by phoenix winnonlin software. |
| renal recovery rate at 30 days | 30 day after intervention period | monitor renal replacement therapy status at 30 days after received maintenance dose |
Countries
Thailand
Contacts
Primary Contactchidtawan Hirunsomboon, PharmD
Outcome results
None listed