此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Impact of Therapeutic Drug Monitoring on Anti-Infective Agents Amongst Severely Burned Patients Requiring ICU Admission

2016年11月10日 更新者:Anne Fournier、University of Lausanne Hospitals

Sepsis is the major cause of morbidity and mortality amongst burn patients. Burn shock and respiratory failure that used to be the major cause of mortality have progressively been replaced by sepsis and multiple organ failure. It is not rare that treatment failures occurs several weeks, or even months after injury as a consequence of sepsis usually caused by multi-drug resistant (MDR) microorganisms. Introduction of early surgery combined with topical and systemic antibiotherapy dramatically enhanced survival from sepsis after burn trauma, but further improvement is impaired by the rapid development of hard-to-treat MDR bacteria.

Correct prescription of anti-infective agents could be one way to curb the steadily increasing development of multidrug resistance. Administration of antibiotic to burn patient is complex: they frequently suffer from kidney dysfunction, they usually experience tremendous shifts of liquids between intra-vascular - inter-cellular and intra-cellular compartments, they often are hypo-albumin and protein-emic, and finally they present with a profoundly modified metabolism. All those aspects make this particular population of patients at high risk of both under or over prescription.

Monitoring of drug concentrations in the plasma of patients, so-called TDM for Therapeutic Drug Monitoring, has been introduced to clinical practice for several decades primarily to avoid toxicity of a small number of drugs with narrow therapeutic windows. However, with the increasing availability of detection techniques, the number of drugs that can be measured in the plasma of patients has grown tremendously over the last decade. As a consequence, it is currently possible to monitor drug concentrations not only to prevent toxicity, but also to improve efficacy. For instance, several studies demonstrated that TDM improved antibiotic prescription in different populations of hospitalized patients, including critically ill patients, with a direct impact on outcome.

Such studies amongst burn patients are however lacking, although this particular population is at high risk to suffer from mis-prescription. We thus hypothesize that systematic TDM could improve antibiotic prescription in this peculiar population. To this end, we propose to implement a 3-year prospective, randomized, mono-centric, clinical trial that will analyze the impact of systematic TDM on anti-infective agent prescription amongst burned patients.

研究概览

研究类型

介入性

注册 (实际的)

39

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Vaud
      • Lausanne、Vaud、瑞士、1011
        • Centre Hospitalier Universitaire Vaudois

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • All adult burn patients (≥ 18 years) admitted to the University Hospital of Lausanne during the study period receiving systemic anti-infectives agents for which TDM is available will be included.

Exclusion Criteria:

  • Patients not receiving systemic anti-infective agents therapy
  • Patients with length of hospital stay <72 hours
  • Patients refusing to give their written consent (or for which the therapeutic representative refuses) or incapable of understanding and lack of legal representative
  • Pregnant or breastfeeding women
  • Children <18 years

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Patients with systematic TDM of anti-infective agents
Patients with systematic TDM of anti-infective agents and dosages adapted accordingly
无干预:Patients treated as usual

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Time required to achieve anti-infective plasma concentrations in the target
大体时间:Up to 3 years
Up to 3 years
Numbers of concentrations within the target during an anti-infective agents course
大体时间:Up to 3 years
Up to 3 years

次要结果测量

结果测量
措施说明
大体时间
Anti-infective agents consumption
大体时间:Up to 3 years
Up to 3 years
Development of antibiotic resistance
大体时间:Up to 3 years
Up to 3 years
Length of ICU stay based on TBSA
大体时间:Up to 3 years
Up to 3 years
Characterization of the pharmacokinetic profile of most widely used antibiotics
大体时间:Up to 3 years
Up to 3 years
Concentration - efficacy analysis
大体时间:Up to 3 years
Population pharmacokinetic (NONMEM software)
Up to 3 years
Failure / resolution rate of infectious episodes
大体时间:Up to 3 years
Up to 3 years
Concentration - toxicity analysis
大体时间:Up to 3 years
Population pharmacokinetic (NONMEM software)
Up to 3 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2013年10月1日

初级完成 (实际的)

2016年10月1日

研究完成 (实际的)

2016年10月1日

研究注册日期

首次提交

2013年9月27日

首先提交符合 QC 标准的

2013年10月17日

首次发布 (估计)

2013年10月18日

研究记录更新

最后更新发布 (估计)

2016年11月11日

上次提交的符合 QC 标准的更新

2016年11月10日

最后验证

2016年11月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • Protocol 195/13

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅