Ertapenem Pharmacokinetics in Patients in Continuous Ambulatory Peritoneal Dialysis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Volume of Distribution, Central Compartment (Vc)
研究概览
简要总结
The objective of this study is to characterize the pharmacokinetic profile of ertapenem during continuous ambulatory peritoneal dialysis (CAPD).
详细描述
BACKGROUND:
Infection is a leading cause of morbidity and mortality in end-stage renal disease (ESRD) patients.[1, 2] Ertapenem is an antibiotic used for the treatment of infections caused by several organisms, including both Gram positive and negative infections.3 Although ertapenem pharmacokinetic (PK) parameters have been described in the general population, this same information for patients on peritoneal dialysis is not available.
Determining optimal antibiotic dosing recommendations for ertapenem is imperative to the health of CAPD patients in order to prevent either excess medication or sub-therapeutic doses of the drug. This study will provide clinicians with the necessary information to safely and effectively treat CAPD patients with ertapenem.
OBJECTIVE The objective of this study is to characterize the pharmacokinetic profile of ertapenem during continuous ambulatory peritoneal dialysis (CAPD).
RESEARCH DESIGN & METHODS:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
ertapenem 500 mg IV x1
All patients will receive ertapenem 500 mg IV once.
干预措施: ertapenem (Drug)
结局指标
主要结局
Volume of Distribution, Central Compartment (Vc)
时间窗: 12h
Population PK
Clearance (CL)
时间窗: 12h
population PK clearance
k12
时间窗: 12h
1st order intercompartmental rate constant between central and peripheral compartments
k21
时间窗: 12h
1st order intercompartmental rate constant from peripheral to central compartment
k13
时间窗: 12h
1st order intercompartmental rate constant from central to peritoneal cavity
k31
时间窗: 12h
1st order intercompartmental rate constant peritoneal cavity to central
Residual Drug in Peritoneal Cavity After 1st Exchange
时间窗: 6h
次要结局
未报告次要终点
研究者
Katie Cardone
Assistant Professor
Albany College of Pharmacy and Health Sciences