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临床试验/NCT01146353
NCT01146353撤回不适用

Pharmacokinetic Assessment of Peramivir in Hospitalized Adults Undergoing Continuous Renal Replacement Therapy

Midwestern University1 个研究点 分布在 1 个国家开始时间: 2010年2月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
The primary outcome measure will be to determine the sieving coefficient for peramivir.

研究概览

简要总结

Pharmacokinetics for peramivir have not been well characterized in patients undergoing continuous renal replacement therapy CRRT - either Continuous veno-venous hemofiltration (CVVH) +/- dialysis (CVVHD). CRRT is commonly utilized in the hospital setting for patients with acute kidney injury for metabolic correction, slow continuous fluid removal, and to maintain hemodynamic stability. CRRT commonly alters drug disposition and clearance, and dosing regimens often need alteration in patients receiving CRRT. Doses required to generate predictable serum concentrations can be calculated from known patient parameters such as replacement fluid and dialysate flow rate, sieving coefficients, and desired serum concentrations. However, pharmacokinetic studies must be performed in CRRT patients to generate drug removal constants or sieving coefficients. Of note, the clearance of drugs by conventional hemodialysis cannot be used to extrapolate clearances with CRRT secondary to differences in ultrafiltration rates and dialysis membranes. The investigators propose an open label study to obtain peramivir pharmacokinetics in patients undergoing CRRT.

详细描述

This study has been closed. No patients were enrolled as the peramivir EUA was rescinded.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

The primary outcome measure will be to determine the sieving coefficient for peramivir.

时间窗: upon study completion (estimated 2 yrs)

次要结局

  • Determine the extracorporeal clearance for peramivir(upon study completion (estimated 2 yrs))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marc Scheetz

Associate Professor

Midwestern University

研究点 (1)

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