Pharmacokinetics of Vancomycin in Patients Receiving Continuous Veno-Venous Hemodiafiltration (CVVHDF) with the Absorptive OXiris Membrane
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- AUC of vancomycin
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Vancomycin
administration with vancomycin 7.5 to 10 mg/kg IV q 12 hours in patient received CRRT with oXiris membrane
干预措施: Vancomycin (Drug)
结局指标
主要结局
AUC of vancomycin
时间窗: 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)
次要结局
- To determine the Cmax of vancomycin(1 year)
- To determine the volume of distribution (Vd) of vancomycin(1 years)
- 30-day mortality rate(30 day after intervention period)
- To determine the elimination rate constant (Ke) of vancomycin(1 years)
- percentage of patients who, receiving AUC/MIC ratio within the range of 400 to 600 mg*h/L.(1 years)
- incidence of adverse effects of vancomycin(1 years)
- renal recovery rate at 30 days(30 day after intervention period)
- To determine the half life of vancomycin(1 years)
研究者
Chidtawan Hirunsomboon
lecturer faculty of pharmacy
Mahidol University