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临床试验/NCT03308214
NCT03308214已完成不适用

The Analysis of Factors Influencing the Apparent Volume of Distribution of Imipenem in Septic Shock Patients

Southeast University, China1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2018年3月18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
发起方
入组人数
25
试验地点
1
主要终点
the apparent volume of distribution

研究概览

简要总结

The study measures the plasma concentrations of imipenem in septic shock patients and non-septic shock patients and observes hypoalbuminemia and the impact of the severity of critical illness on Vd

详细描述

Severe sepsis and septic shock are major causes of mortality in intensive care unit(ICU) patients.Correct and adequate antibiotic coverage is essential but can be complex as a result of fluid resuscitation, hypoalbuminemia, organ dysfunction, the application of extracorporeal support modalities and the impact of critical illness on pharmacokinetics(PK).Such changes will significantly distort the normal anti-biotic PK profile, resulting in drug exposure that is markedly different from the 'healthy volunteer.'The apparent volume of distribution is one of important PK parameters.Vd determines the loading dose. This review article considers these issues in detail, summarizing the key changes in antibiotic Vd in the critically ill, and providing general suggestions how to optimization of antibiotic dosing to manage Vd challenges.50 patients who receives the theapy of imipenem are included in this study.Whether hypoalbuminemia, organ dysfunction, the application of extracorporeal support modalities and the impact of critical illness on Vd will be evaluted.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age between 18 years old and 80 years old;
  • Admitted to the ICU;
  • Patients diagnosed as septic shock requiring the therapy of imipenem(0.5g q6h or 1.0g q8h;

排除标准

  • Patient participated in another interventional trial before enrollment
  • Allergy, hypersensitivity or a serious reaction to imipenem;
  • patients with ECMO and(or)CRRT.

研究组 & 干预措施

septic shock

Patients with septic shock treat with Imipenem

干预措施: Imipenem (Drug)

non-septic shock

Patients with infection but not septic shock treat with Imipenem

干预措施: Imipenem (Drug)

结局指标

主要结局

the apparent volume of distribution

时间窗: Day1, Day 3, Day 7

The imipenem plasma concentrations are measured at different time to calculate Vd

次要结局

未报告次要终点

研究者

发起方
Southeast University, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Songqiao Liu

MD. PHD

Southeast University, China

研究点 (1)

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