drugset / Trial / NCT06543940
Pharmacokinetics Vancomycin CVVHDF with OXiris Membrane
NaSingle-groupOpen-labelBasic science
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.
Timeline
- Start
- 2024-09-01
- Primary completion
- 2025-08-01
- Completion
- 2025-12-31
Publications
- Background 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.
- Background 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 Pediatric Infectious Diseases Society, and the Society of Infectious Diseases Pharmacists. Am J Health Syst Pharm. 2020 May 19;77(11):835-864. doi: 10.1093/ajhp/zxaa036. No abstract available.
- Background 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.
- Background 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.
- Background 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vancomycin | Other / unclassified | 7.5 mg/kg | Intravenous |
| Subject | Vancomycin | Other / unclassified | 10 mg/kg | Intravenous |