Impact of Capillary Leak and Hypoalbuminemia on PK/PD of Anidulafungin and Caspofungin in Critically Ill Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Average plasma concentration
研究概览
简要总结
This prospective study will explore the pharmacokinetic exposure and pharmacodynamics of the echinocandins (caspofungin or anidulafungin) in critically ill patients.
详细描述
This non-randomized, monocenter pharmacokinetic study will be carried out in critically ill patients receiving multiple dose treatment with echinocandins (caspofungin or anidulafungin).
The pharmacokinetics and pharmacodynamics of the echinocandins in plasma and BAL will be determined. Especially, the relative contributions of two pathophysiological alterations (capillary leak and hypoalbuminemia) encountered in critically ill patients, will be explored.
Also other correlating covariates will be identified to provide a rationale for optimal dosing strategy in critically ill patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Treatment with anidulafungin or caspofungin
- •Admitted to an ICU ward
排除标准
- •< 18 years
- •DNR 2 or 3
结局指标
主要结局
Average plasma concentration
时间窗: July 2020
The average plasma concentration will be calculated
Volume of distribution (Vd)
时间窗: July 2020
The volume of distribution will be calculated
Minimum plasma concentration
时间窗: July 2020
The median minimum plasma concentration will be reported
Maximum plasma concentration
时间窗: July 2020
The median maximum plasma concentration will be reported
Area under the curve (AUC)
时间窗: July 2020
The area under the concentration-time curve will be calculated
Half-life (T1/2)
时间窗: July 2020
The half-life will be calculated
Clearance (CL)
时间窗: July 2020
The clearance will be calculated
次要结局
- Influence of fluid balance (mL) on echinocandin-exposure(July 2020)
- Influence of VEGF on echinocandin-exposure(July 2020)
- Influence of gamma-GT on echinocandin-exposure(July 2020)
- Influence of SOFA ( sequential organ failure assessment) score on echinocandin-exposure(July 2020)
- Influence of total protein on echinocandin-exposure(July 2020)
- Influence of serum creatinin (mg/dL) on echinocandin-exposure(July 2020)
- Influence of AST on echinocandin-exposure(July 2020)
- Influence of ALT on echinocandin-exposure(July 2020)
- Influence of glomerular filtration rate (ml/min) on echinocandin-exposure(July 2020)
- Influence of on bilirubin on echinocandin-exposure(July 2020)
- Influence of APACHE II (Acute Physiology and Chronic Health Evaluation II) score on echinocandin-exposure(July 2020)
- Influence of serum albumin on echinocandin-exposure(July 2020)
- Influence of alkaline phosphatase on echinocandin-exposure(July 2020)
- Influence of Ang-1 on echinocandin-exposure(July 2020)
- Influence of Ang-2 on echinocandin-exposure(July 2020)
- Influence of prothrombin time on echinocandin-exposure(July 2020)
- Influence of inflammation (CRP) on echinocandin-exposure(July 2020)