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临床试验/NCT01702545
NCT01702545Unknown不适用

Determination of Drugs and Their Metabolites in Hospitalized Patients

Klinikum Nürnberg1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2012年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,000
试验地点
1
主要终点
Plasma concentrations [ng/mL] of various drugs at different timepoints

研究概览

简要总结

The current state of knowledge on the concentration of drugs and their metabolites in the individual human body is not satisfying concerning the question about behavior of drugs in the human body, taking into account individual patient factors such as age, weight and organ dysfunctions.

This projects deals with the question of drug levels in the blood of hospitalized patients.

The aim of this study is to extend the knowledge about the behavior of drugs in the human body significantly, for the safety and benefit of future patients. This also includes to establish a relationship between drug levels in patients and the desired and undesired effects of a drug.

As a result, the future perspective is to find the optimal dose for the individual patient by measuring the blood concentration of a drug.

详细描述

The primary goal of the study is to gain an overview of the plasma concentrations of relevant drugs which occur in different patient populations and to what extent they are consistent with those concentrations described in the literature.

If the expectation is confirmed, that a significant heterogeneity in the plasma concentrations of these patients exists, the investigators will try to find influencing factors for this circumstance on the basis of routine clinical parameters (height, weight, renal function, concomitant medications, etc.).

Ultimately, this project will identify substances with a high interindividual variability in plasma levels, where drug monitoring might be suggested.

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

入选标准

  • legal capacity

排除标准

  • severe anemia

结局指标

主要结局

Plasma concentrations [ng/mL] of various drugs at different timepoints

时间窗: up to five years

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

Mr. Prof. Dr. Wilhelm

Prof. Dr. med. Martin Wilhelm

Klinikum Nürnberg

研究点 (1)

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