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临床试验/NCT04358991
NCT04358991已完成不适用

Pharmacokinetics of Ceftazidime-avibactam Among Critically-ill Patients Receiving Continuous Venovenous Hemodiafiltration

University of Pittsburgh1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Serum Levels of Ceftazidime and Avibactam Among Critically-ill Patients

研究概览

简要总结

Ceftazidime-avibactam is used for treatment of invasive Gram-negative bacterial infections among critically ill patients, including those on continuous venovenous hemodiafiltration . However, dosing of ceftazidime-avibactam for these patients remains undefined. The purpose of this study was to evaluate the pharmacokinetics of ceftazidime and avibactam among critically-ill patients, including those receiving CVVHD. This is a registration of Dr. Shields' exempt project under IRB approved research study STUDY19040363

详细描述

Patients who received ceftazidime-avibactam as part of their clinical care were consented. EMR data was collected as well as PK sampling around their dosing to include the following samples immediately pre-dose, then at the following times thereafter: 1, 2, 4, 6, and 8 hours. Blood samples were collected in lithium-heparin tubes from a central venous catheter that is not being used for the continuous venovenous hemodiafiltration. The tubes were centrifuged at 2500 rpm for 10 minutes within 1 hour from collection and the samples will be frozen at 80°C. The total concentrations of ceftazidime and avibactam were determined simultaneously from plasma by using a validated HPLC-tandem MS assay. Noncompartmental pharmacokinetics were calculated using the linear-up and logarithmic-down trapezoidal method, based on the assumption of first-order elimination.

研究设计

研究类型
Observational
观察模型
Other
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

  • Adult patients receiving ceftazidime-avibactam as standard care

排除标准

  • Less than 18 years-old

研究组 & 干预措施

invasive bacterial infections

patients who are receiving Ceftazidime-avibactam are asked to provide blood samples around a dosing of the medication for analysis of samples

干预措施: Ceftazidime-avibactam (Drug)

结局指标

主要结局

Serum Levels of Ceftazidime and Avibactam Among Critically-ill Patients

时间窗: 8 hours

PK samples obtained around standard of care dosing regimens immediately before and at 1, 2, 4, 6, and 8 hours after administration

次要结局

未报告次要终点

研究者

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

Ryan Shields

Associate Professor

University of Pittsburgh

研究点 (1)

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