Ganciclovir Pharmacokinetics in Patients Undergoing Continuous Renal Replacement Therapy
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- comparing the total clearance with the RRT derived clearance of GCV
研究概览
简要总结
In order to optimize anti-cytomegalovirus (CMV) treatment with ganciclovir (GCV), in patients with multi organ failure treated with continuous renal replacement therapy (RRT), more information about ganciclovir pharmacokinetics in this setting is needed.
The primary objective is to describe the pharmacokinetics of ganciclovir in critically ill patients with acute renal failure treated with continuous renal replacement therapy, with a special emphasis on the extra-renal clearance and distribution volume.
Secondary objectives are to investigate if any co-factors, such as serum creatinine, weight, general hydration status, rest function of the native kidneys, etc. can help to describe the pharmacokinetics of GCV in these patients on continuous RRT as well as the relative influence of filtrations and dialysis on GCV elimination during different modalities of the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Patients in need of continuous RRT and GCV treatment
- •18 years of age or older.
排除标准
- •Concomitant treatment with acyclovir or valacyclovir.
- •Patient does not give informed consent.
结局指标
主要结局
comparing the total clearance with the RRT derived clearance of GCV
comparing the volume of distribution with historic controls of non Intensive Care Unit (ICU) patients
次要结局
- comparing GCV plasma concentration and population model derived estimates of these concentrations when including different relevant clinical co-factors such as: weight, S-creatinine, CL-creatinine, hydration, albumin, rest function of native kidneys etc.
- determine RRT derived GCV clearance during the different filtration/dialysis settings of the RRT machine