Pharmacokinetics Vancomycin CVVHDF with OXiris Membrane

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Vancomycin
  vancomycin dose is 7.5 to 10 mg/kg

Первичные конечные точки

• AUC of vancomycin [Срок оценки: at 0 pre-dose, 2,3,4,5,6,8 and 12 hours after intervention vancomycin]

Вторичные конечные точки (8)

• To determine the Cmax of vancomycin [Срок оценки: 1 year]
• 30-day mortality rate [Срок оценки: 30 day after intervention period]
• percentage of patients who, receiving AUC/MIC ratio within the range of 400 to 600 mg*h/L. [Срок оценки: 1 years]
• incidence of adverse effects of vancomycin [Срок оценки: 1 years]
• renal recovery rate at 30 days [Срок оценки: 30 day after intervention period]
• To determine the elimination rate constant (Ke) of vancomycin [Срок оценки: 1 years]
• To determine the volume of distribution (Vd) of vancomycin [Срок оценки: 1 years]
• To determine the half life of vancomycin [Срок оценки: 1 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Таиланд · 1 центр

• Facullty of Pharmacy Mahidol University — Bangkok

Публикации

• 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

Идентификаторы

NCT: NCT06543940 · MUPY00001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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