Pharmacokinetics of Caspofungin in Critically Ill Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Serum concentration of caspofungin
研究概览
简要总结
The objective of this study is to describe the pharmacokinetics of standard doses of caspofungin in critically ill patients.
详细描述
This is a prospective observational study performed on critically ill patients. Inclusion criteria are: severe sepsis on admission requiring broad-spectrum antibiotics. Both medical and surgical patients will be included. Any type of infections will be included (pulmonary, abdominal, urinary tract, etc.) Antibiotics regimen includes: broad spectrum anti-bacterial antibiotics plus caspofungin (70 mg i.v. on the first day day, and 50 mg i.v. on the consecutive days, once daily.
Blood samples (3 mL) will be collected 2, 4, 8,12 and 24 hours after each dose of caspofungin for 3 consecutive days. The standard arterial canula will be used to obtain samples.
30 minutes after each sample collection, blood will be centrifuged for 10 minutes at 3,000 rpms. Subsequently, supernatant will be collected and frozen.
Serum caspofungin concentration will be measured with high performance liquid chromatography.
Each patient's hemodynamics parameters will be recorded with the use of transpulmonary thermodilution technique (PICCO). Other therapies i.e.: ventilatory support, sedation, an antifungal agent will be given as required.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who require ICU treatment due to severe sepsis age
- •18-80 years
- •an eligible consent obtained from the patient or his/her attendant
排除标准
- •allergy to caspofungin
- •lack of consent to participate in the study
- •age of patients below 18 or above 80 years
研究组 & 干预措施
Caspofungin
Each patient will receive: caspofungin i.v. once daily ( 70 mg on the first day, 50 mg on the 2 and 3 day
干预措施: Caspofungin (Drug)
结局指标
主要结局
Serum concentration of caspofungin
时间窗: 72 hours for each patient from the tigecycline treatment initiation
Samples obtain from ICU patients 2, 4, 8 12 and 24hours after each dose of caspofungin for 3 days.
次要结局
未报告次要终点
研究者
Michał Borys
associate professor
Medical University of Lublin