Offene, Monozentrische, Nicht Kontrollierte Und Nicht Randomisierte Phase IV-Studie Zur Bestimmung Der Pharmakokinetik Von Carbapenemen in adipösen Patienten.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Unbound concentration of ertapenem and meropenem in fatty tissue and peritoneal fluid
研究概览
简要总结
Tissue kinetics of ertapenem and meropenem in fatty tissue, intraperitoneal fluid and plasma.
详细描述
The purpose of this study is to determine the free tissue kinetics of ertapenem and meropenem in fatty tissue and intraperitoneal fluid up to 24 hours after administration of the IMP.
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
- Basic Science
- 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
- •Hospitalized patients 18 years or older requiring elective surgical intervention (open or laparoscopic surgery) at intraabdominal organs
- •BMI more or even 40
- •written informed consent
排除标准
- •BMI < 40
- •pregnancy or lactation in women
- •emergency surgery
- •history of serious allergy or intolerance to β-lactam antibiotics
- •systemic antimicrobial therapy with ceftazidime (internal standard of high-performance liquid chromatography / mass spectrometry) within a 7 days period prior to study entry
- •ongoing intraabdominal infections
- •terminal illness
- •severe diseases of the liver, e.g. cirrhosis of the liver with ALT or AST > 6 x upper limit of normal (ULN) and bilirubin > 3 x ULN
- •severe renal insufficiency with a creatinine clearance ≤30 mL/min.
- •neutrophil count < 1000 cells/mm3
- •platelets < 75000 cells/mm3
- •coagulation studies (INR) > 1.5 x ULN
- •ongoing chemotherapy and/or radiotherapy
- •ongoing therapy with valproin acid (in case of ertapenem administration).
研究组 & 干预措施
Ertapenem
Free tissue kinetics of ertapenem in fatty tissue and intraperitoneal fluid in mg/L
Free and bound plasma concentration of ertapenem or meropenem in mg/L
干预措施: microdialysis catheter (Procedure)
Meropenem
Free tissue kinetics of meropenem in fatty tissue and intraperitoneal fluid in mg/L up to 24 hours after administration. Free and bound plasma concentration of meropenem in mg/L.
干预措施: microdialysis catheter (Procedure)
结局指标
主要结局
Unbound concentration of ertapenem and meropenem in fatty tissue and peritoneal fluid
时间窗: within 24 h after administration
次要结局
- Number of Adverse Events (total and per patient)(Participants will be followed for the duration of hospital stay, an expected average of 3 weeks)
- Number of Serious Adverse Events (total and per patient)(Participants will be followed for the duration of hospital stay, an expected average of 3 weeks)
- Number of Suspected Unexpected Serious Adverse Reactions (SUSARs)(Participants will be followed for the duration of hospital stay, an expected average of 3 weeks)
研究者
M. Wittau
MD
University of Ulm