Clinical trial NCT06543940: Pharmacokinetics Vancomycin CVVHDF with OXiris Membrane
Official title: Pharmacokinetics of Vancomycin in Patients Receiving Continuous Veno-Venous Hemodiafiltration (CVVHDF) with the Absorptive OXiris Membrane
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: AKI - Acute Kidney Injury
Keywords: vancomycin
CRRT
oXiris membrane
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: AUC of vancomycin
timeFrame: at 0 pre-dose, 2,3,4,5,6,8 and 12 hours after intervention vancomycin
Secondary outcomes:
measure: To determine the Cmax of vancomycin
timeFrame: 1 year
measure: 30-day mortality rate
timeFrame: 30 day after intervention period
measure: percentage of patients who, receiving AUC/MIC ratio within the range of 400 to 600 mg*h/L.
timeFrame: 1 years
measure: incidence of adverse effects of vancomycin
timeFrame: 1 years
measure: renal recovery rate at 30 days
timeFrame: 30 day after intervention period
measure: To determine the elimination rate constant (Ke) of vancomycin
timeFrame: 1 years
measure: To determine the volume of distribution (Vd) of vancomycin
timeFrame: 1 years
measure: To determine the half life of vancomycin
timeFrame: 1 years
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Facullty of Pharmacy Mahidol University
state: Payathi
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.