Pharmacokinetics of High-dose Tigecycline in Critically Ill Patients: an Observational, Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Serum concentration of tigecycline
研究概览
简要总结
The objective of this study is to describe the pharmacokinetics of tigecycline in critically ill patients receiving continuous venovenous haemodialysis (CVVHD) and to evaluate the frequency of pharmacokinetic/pharmacodynamic target attainment with high dosing strategy (200 mg loading dose and 100 mg/12h).
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: tigecycline (200 mg every 12 hours intravenously), meropenem (2 grams every 8 hours intravenously).
Blood samples (3 mL) will be collected 2, 4, 8 and 12 hours after each dose of tigecycline for 3 consecutive days. The standard arterial canula will be used to obtain samples.
In each case CVVHD will be started and continued for at least 3 days' period. 30 minutes after a collection each sample will be centrifuged for 10 minutes at 3,000 rpms. Subsequently, supernatant will be collected and frozen.
Serum tigecycline 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
- •CVVHD treatment
- •an eligible consent obtained from the patient or his/her attendant
排除标准
- •allergy to tigecycline or meropenem
- •contraindication to CVVHD
- •lack of consent to participate in the study
- •age of patients below 18 or above 80 years
结局指标
主要结局
Serum concentration of tigecycline
时间窗: 72 hours for each patient from the tigecycline treatment initiation.
Samples obtain from ICU patients 2, 4, 8 12 hours after each dose of tigecycline 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