Pharmacokinetics and Investigation of Optimal Dose of Invanz (Ertapenem) in Hemodialysis Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Mean Maximum Concentration (Cmax) of Ertapenem in Hemodialysis Patients
研究概览
简要总结
The purpose of this study is to determine the amount of ertapenem in the blood over time between hemodialysis session.
详细描述
After a hemodialysis session, subject will be administered ertapenem and the amount of ertapenem in the blood will be measured at seven time periods before the initiation of the next hemodialysis session.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 88 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women age between 18 and 88 at the time of admission to Oakwood Hospital and Medical Center during January 1, 2014 or date of Institutional Review Board (IRB) approval to December 1, 2015
- •Diagnosed with end stage renal disease and requires hemodialysis three times a week
- •No allergy to β lactam medications
- •Existing IV access for parenteral ertapenem infusion
- •Willing for blood draws, at predose, 0.5, 1, 2, 6, 12 hours post-hemodialysis and pre-hemodialysis for the following hemodialysis and immediately post hemodialysis session and 1 hour post.
- •No evidence of hepatic disease
- •No history of alcoholism or drug abuse within pervious 2 years
- •Not pregnant
排除标准
- •History of any form of epilepsy, seizure or convulsion
- •Currently taking any forms of valproic acid or divalproex sodium for treatment of any disease states
- •Currently taking probenecid
- •Current Clostridium difficile (C. diff.) infection, defined as 30 days prior to day-1 of receiving ertapenem for this study
- •Currently receiving any antimicrobial agents for prophylaxis or treatment
研究组 & 干预措施
Ertapenem
Subjects with end stage renal disease (ESRD) who undergo hemodialysis three times a week and without infection will be administered one gram of ertapenem once over five minutes through infusion access after a hemodialysis session, and will have blood drawn at time 0, 0.5, 1, 2, 6, and 12 hours after the ertapenem administration and once prior to the next hemodialysis session
干预措施: Ertapenem (Drug)
结局指标
主要结局
Mean Maximum Concentration (Cmax) of Ertapenem in Hemodialysis Patients
时间窗: once after hemodialysis session prior to ertapenem administration and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session
Mean Cmax will be calculated from a series of ertapenem concentration from the blood samples, i.e.once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session
Mean Area Under the Curve (AUC) of Ertapenem in Hemodialysis Patients
时间窗: once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session
Mean AUC will be calculated from a series of ertapenem concentration from the blood samples, i.e.once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session
Mean Minimum Concentration (Cmin) of Ertapenem in Hemodialysis Patients
时间窗: once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session
Mean Cmin will be calculated from a series of ertapenem concentration from the blood samples, i.e.once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session
Mean Terminal Half Life (t1/2) of Ertpenem in Hemodialysis Patients
时间窗: once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session
Mean t1/2 will be calculated from a series of ertapenem concentration from the blood samples, i.e.once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session
Mean Time to Cmax of Ertapenem in Hemodialysis Patients
时间窗: once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session
Mean time to Cmax will be calculated from a series of ertapenem concentration from the blood samples, i.e.once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session
次要结局
- Number of Participants With Headache(Up to seven days after the administration of ertapenem)
- Number of Participants With Diarrhea(Up to seven days after the administration of ertapenem)
- Number of Participants With Nausea and Vomiting(Up to seven days after the administration of ertapenem)
- Number of Participants With Injection Site Reaction(Up to seven days after the administration of ertapenem)