Population Pharmacokinetics of L-AmB in Chinese Patients Assisted by Extracorporeal Membrane Pulmonary Oxygenation (ECMO)
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Blood drug concentration of liposomal amphotericin B
研究概览
简要总结
The goal of this study is to investigate the effects of ECMO-assisted therapy on L-AmB PK parameters in patients with critically ill patients of invasive fungal infections, and to determine the in vivo pharmacokinetic changes of L-AmB in the ECMO population. To establish and validate a population pharmacokinetic model for liposomal amphotericin B in patients with critically ill patients of invasive fungal infections treated with ECMO adjuvant therapy, and to explore the pharmacokinetics/pharmacodynamics of the drug with different dosing regimens.
详细描述
The information of patient characteristics, physiological parameters, ECMO related parameters, administration and sampling information of L-AmB were collected.Patients were intravenously titrated after 3 doses of maintenance dose titration. The sampling window was from 0 to 24 h. The time points were 0.5 h before and 1, 2, 3, 6, 9, 12, 16, 20 and 24 h after administration. NONMEM software was applied to establish the PPK model of L-AmB.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Diagnostic criteria for invasive fungal infections presenting to the intensive care unit (ICU) with probable or proved patients According to the 2021 EORTC/MSGERC guideline.
- •Requiring ECOM assistance.
- •Age 18 years.
排除标准
- •Intolerance of L-AmB therapy.
- •Pregnancy.
- •Expected survival time <24 hours.
- •Lack of necessary data on patient demographics physiopathology, and clinical status.
研究组 & 干预措施
L-AmB group
To establish and validate a population pharmacokinetic model for L-AmB in patients with severe invasive fungal infections treated undergoing ECMO-assisted therapy.
干预措施: Determination of blood drug concentration (Biological)
结局指标
主要结局
Blood drug concentration of liposomal amphotericin B
时间窗: The time points of sample collecting were 30 minutes before and 1, 2, 3, 6, 9, 12, 16, 20, 24 hours after administration.
Patients were intravenously titrated after 3 doses of maintenance dose titration of L-AmB. Then collecting blood samples from these patients. The blood concentrations of L-AmB were determined according to the established method.
次要结局
未报告次要终点
研究者
Lin Yang
Director of pharmacy department of Beijing Anzhen Hospital
Beijing Anzhen Hospital