Konzentrationen Von Ertapenem in Kolorektalem Gewebe
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Concentration of Ertapenem in Colorectal Tissue in mg/kg 3 to 6 Hours After a Single Dose of 1 Gram Ertapenem I.V..
研究概览
简要总结
The purpose of this study is to determine the tissue kinetics of ertapenem in colonic tissue from three hours up to six hours (25% of dosing interval) after administration of ertapenem.
详细描述
The purpose of this study is to determine the tissue kinetics of ertapenem in colorectal tissue from three hours up to six hours (25% of dosing interval) after administration of ertapenem before an elective surgical intervention (open or laparoscopic surgery) at the colon/rectum. Subjects are patients. Hospitalized patients 18 years or older requiring elective surgical intervention (open or laparoscopic surgery) at the colon will be eligible for this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 90 Years（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 the colon will be eligible for this study.
- •Patients with benignant disorders (e.g. colonic diverticulosis) will be preferred.
排除标准
- •Pregnancy or lactation in women
- •Emergency surgery, history of serious allergy or intolerance to β-lactam antibiotics and other carbapenems
- •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
- •Chronic immunosuppressive therapy
- •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 and coagulation studies (INR) > 1.5 x ULN, ongoing therapy with valproin acid.
研究组 & 干预措施
Ertapenem
Administration of 1 gram ertapenem I.V.
干预措施: Ertapenem (Drug)
结局指标
主要结局
Concentration of Ertapenem in Colorectal Tissue in mg/kg 3 to 6 Hours After a Single Dose of 1 Gram Ertapenem I.V..
时间窗: 3 to 6 hours after a single dose of 1 gram ertapenem I.V..
Tissue (Total) Concentrations of Ertapenem in the Colorectal Tissue
时间窗: The mean (+- SD) tissuetotal concentrations of ertapenem in the colorectal tissue as an average of every 30 miuntes up to 10 hours
The mean (+- SD) tissuetotal concentrations of ertapenem in the colorectal tissue every 30 minutes up to 10 hours
次要结局
- Safety Assessment(0 to approx. 14 days after admission)
研究者
M. Wittau
MD
University of Ulm