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临床试验/NCT03714789
NCT03714789已完成不适用

Clearance and Pharmacokinetics of Antibiotics With Different Protein-bound Levels in Renal Replacement Therapy

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2017年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
19
试验地点
1
主要终点
Area under the concentration-time curve (AUC)

研究概览

简要总结

This is an observational study that evaluates the dialysis clearance and pharmacokinetics of antibiotics with different protein-bound levels in patients receiving renal replacement therapy. Meropenem, vancomycin and ceftriaxone are selected to represent three typical protein-bound levels, and the primary dialysis methods being studied are intermittent hemodialysis(IHD) and hemodiafiltration(HDF). During and after the dialysis, the drug levels in both plasma and spent dialysate are monitored, but no changes are made to therapy. The study will provide detailed information on the characteristics of the removal kinetics of the three antibiotics during dialysis, and evaluate whether the dosing regimens are the most appropriate to achieve therapeutic targets while minimizing the risk of toxicity.

详细描述

This prospective, single-center observational study is taken to evaluate the dialysis clearance and pharmacokinetics of antibiotics with three different protein-bound levels in patients receiving renal replacement therapy. As is known that the plasma protein binding rate affects the distribution, metabolism and elimination of the drug in the body, and is also an important factor affecting the removal during dialysis, the study selects meropenem, vancomycin and ceftriaxone, of which the protein-bound levels are respectively 2%, 55% and 85%, to represent three typical protein-bound levels. The primary dialysis methods being studied are intermittent hemodialysis(IHD) and hemodiafiltration(HDF). The dialysis pattern, the antibiotic choice and its dosage for each subject are made on clinical grounds. A total of 16 milliliters of blood and 60 milliliters of spent dialysate are collected from each subject for each dialysis pattern. The study will provide detailed information on the characteristics of the removal kinetics of the three antibiotics during dialysis, and evaluate whether the dosing regimens are the most appropriate to achieve therapeutic targets while minimizing the risk of toxicity.

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 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • With Age from 18 to 85 years old.
  • With weight from 50 to 75 kilograms.
  • Requiring dialysis including intermittent hemodialysis(IHD) or hemodiafiltration(HDF).
  • Receiving meropenem, vancomycin or ceftriaxone based on clinical grounds.

排除标准

  • Patient is during pregnant or lactation period.
  • Patient is allergic to meropenem, vancomycin or ceftriaxone.
  • Severe hypoproteinemia (serum total protein<=45g/L) or severe hypoalbuminemia(serum albumin<20g/L).
  • Severe liver dysfunction(ALT>200U/L or AST>200U/L).
  • The patient himself or his immediate family refuses to sign the informed consent.

结局指标

主要结局

Area under the concentration-time curve (AUC)

时间窗: During the session of dialysis, up to 4 hours

AUC based on plasma concentration during dialysis

Dialytic clearance (K_total)

时间窗: During the session of dialysis, up to 4 hours

The total drug amount removed by dialysis

次要结局

  • Rebound of plasma concentration (Rebound_1h%)(At the end of dialysis and an hour after dialysis)

研究者

发起方
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ding Feng

Kidney internal medicine professor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

研究点 (1)

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