Pharmacokinetics of Daptomycin in Critically Ill Patients Receiving Continuous Venovenous Hemodialysis (CVVHD)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Daptomycin Transmembrane Clearance by Continuous Venovenous Hemodialysis
研究概览
简要总结
Daptomycin is an antibiotic that is affective against many strains of antibiotic resistant microorganisms. This antibiotic would be appropriate for use in the intensive care unit (ICU) considering the severity of illness and high risk for infection within this hospital environment. While in the ICU, patients may develop acute renal failure. Approximately 75% of ICU patients who develop acute renal failure will require some form of renal replacement therapy until their kidneys recover. Continuous hemodialysis is becoming one of the most common forms of dialysis in the ICU as it is a gentle type of dialysis provided over longer periods of time. The current data demonstrating the ability of continuous hemodialysis to remove daptomycin from the body is derived from in-vitro trials. The purpose of this trial is to determine the extent of daptomycin removal from critically ill patients receiving continuous hemodialysis. Findings from this trial will be used to develop new dosing recommendations for daptomycin in continuous hemodialysis.
详细描述
Daptomycin is a FDA approved antibiotic. This pharmacokinetic trial will monitor daptomycin drug concentrations during continuous hemodialysis. The daptomycin concentration profiles developed from this study will assist in developing a dose recommendation that will result in daptomycin levels that are safe and within therapeutic ranges, as previously identified, in critically ill patients with acute renal failure treated with continuous hemodialysis.
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
- 否
入选标准
- •=/> 18 years of age
- •Prescribed Continuous Venovenous Hemodialysis (CVVHD) as determined by the primary physician
- •Prescribed daptomycin as determined by the primary physician
- •Informed consent granted
排除标准
- •< 18 years of age
- •Allergy to daptomycin
- •Patients being primarily treated with daptomycin for diagnosis of osteomyelitis, meningitis, or pneumonia without adequate concomitant use of other more effective antimicrobial agents as daptomycin is not indicated for primary treatment of these types of infections
- •Inability to complete 48 hours of Continuous Venovenous Hemodialysis (CVVHD)
- •Concurrent use of other extracorporeal therapies such as Extracorporeal Membrane Oxygenation (ECMO) or plasmapheresis and intermittent hemodialysis
- •Inability to obtain informed consent
- •Pregnant and/or breastfeeding women
结局指标
主要结局
Daptomycin Transmembrane Clearance by Continuous Venovenous Hemodialysis
时间窗: From time of daptomycin administration to 48 hours post dose when subjects were also receiving continuous venovenous hemodialysis
Quantifies the rate of daptomcyin removal by continuous venovenous hemodialysis.
次要结局
- Daptomycin Free Fraction(From time of daptomycin administration to 48 hours post dose)
- Daptomycin Dose Actually Administered(Time of daptomycin administration)
- Observed Daptomycin Peak Serum Concentration(At the end of the daptomycin intravenous infusion (at approximately 30 minutes))
- Daptomycin Volume of Distribution at Steady State(From time of daptomycin administration to 48 hours post dose)
- Daptomycin Half-life(From time of daptomycin administration to 48 hours post dose when subjects were also receiving continuous venovenous hemodialysis)
- Daptomycin Total Body Clearance(From time of daptomycin administration to 48 hours post dose when subjects were also receiving continuous venovenous hemodialysis)