Pharmacokinetics Vancomycin CVVHDF with OXiris Membrane
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vancomycin.
- Who it may be relevant to
- Registry conditions: AKI - Acute Kidney Injury. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Thailand
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pharmacokinetics of Vancomycin in Patients Receiving Continuous Veno-Venous Hemodiafiltration (CVVHDF) with the Absorptive OXiris Membrane
Overview
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
- Drug Vancomycin
vancomycin dose is 7.5 to 10 mg/kg
Primary outcome measures
- AUC of vancomycin [Time frame: at 0 pre-dose, 2,3,4,5,6,8 and 12 hours after intervention vancomycin]
Secondary outcome measures (8)
- To determine the Cmax of vancomycin [Time frame: 1 year]
- 30-day mortality rate [Time frame: 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]
- incidence of adverse effects of vancomycin [Time frame: 1 years]
- renal recovery rate at 30 days [Time frame: 30 day after intervention period]
- To determine the elimination rate constant (Ke) of vancomycin [Time frame: 1 years]
- To determine the volume of distribution (Vd) of vancomycin [Time frame: 1 years]
- To determine the half life of vancomycin [Time frame: 1 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
Thailand · 1 center
- Facullty of Pharmacy Mahidol University — Bangkok
Publications
- Bruniera FR, Ferreira FM, Saviolli LR, Bacci MR, Feder D, da Luz Goncalves Pedreira M, Sorgini Peterlini MA, Azzalis LA, Campos Junqueira VB, Fonseca FL. The use of vancomycin with its therapeutic and adverse effects: a review. Eur Rev Med Pharmacol Sci. 2015 Feb;19(4):694-700. PMID 25753888
- Rybak MJ, Le J, Lodise TP, Levine DP, Bradley JS, Liu C, Mueller BA, Pai MP, Wong-Beringer A, Rotschafer JC, Rodvold KA, Maples HD, Lomaestro BM. Therapeutic monitoring of vancomycin for serious methicillin-resistant Staphylococcus aureus infections: A revised consensus guideline and review by the American Society of Health-System Pharmacists, the Infectious Diseases Society of America, the Pediat PMID 32191793
- DelDot ME, Lipman J, Tett SE. Vancomycin pharmacokinetics in critically ill patients receiving continuous venovenous haemodiafiltration. Br J Clin Pharmacol. 2004 Sep;58(3):259-68. doi: 10.1111/j.1365-2125.2004.02143.x. PMID 15327585
- Chaijamorn W, Jitsurong A, Wiwattanawongsa K, Wanakamanee U, Dandecha P. Vancomycin clearance during continuous venovenous haemofiltration in critically ill patients. Int J Antimicrob Agents. 2011 Aug;38(2):152-6. doi: 10.1016/j.ijantimicag.2011.04.010. Epub 2011 Jun 1. PMID 21636256
- Onichimowski D, Nosek K, Ziolkowski H, Jaroszewski J, Pawlos A, Czuczwar M. Adsorption of vancomycin, gentamycin, ciprofloxacin and tygecycline on the filters in continuous renal replacement therapy circuits: in full blood in vitro study. J Artif Organs. 2021 Mar;24(1):65-73. doi: 10.1007/s10047-020-01214-8. Epub 2020 Oct 8. PMID 33033945
Identifiers
NCT: NCT06543940 · MUPY00001