Quantification of Drugs and Their Metabolites in Patients at the Cologne University Hospital
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Pharmacokinetic Outcome Measures (e.g., Cmax, AUC)
研究概览
简要总结
The study includes two study parts in which blood is collected from the patients.
Study part A (observational study, already received positive ethics committee vote; Our sign: 12-330): Use of blood samples gathered during routine blood withdrawal Study part B (interventional study in the sense of additional blood samples but without an investigational product): Optional, for further pharmacokinetic questions: blood withdrawal with a maximum of 20 ml ( ten tubes of 2 ml each) within a maximal study length of four weeks.
The primary objective of this study is to gain an overview about drug concentrations in plasma and/or cerebrospinal fluid (CSF), in order to determine pharmacokinetics of drugs in patients. Any drug may be tested, however the initial focus is on antiinfective, antineoplastic, and antipsychotic drugs.
Many published studies show that there is a profound lack of information on pharmacokinetics and interactions of many commonly used drugs in clinical routine, and that drug concentrations, if controlled by therapeutic drug monitoring, are not in the therapeutic range (provided that such ranges are known at all).
详细描述
For an effective pharmacotherapy in patients with different demographic characteristics (age, weight or lean body mass), there is often a lack of information on the dosage of drugs.
The predictability of the action of a drug is additionally impaired by genetic predisposition. Even if the effect of genetic variants has been demonstrated, the respective characteristic for the patient is usually not known.
For example, a study (Gamelin et al., 2008) of the "old" cytostatic drug 5-fluorouracil shows its genetically-dependent efficacy.
Only in about one third of patients does the concentration reach the desired therapeutic range (the dosage adjusted to body surface).
There is a significant lack of information on the pharmacokinetics, especially in critically ill patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both genders are included.
- •Patients willing and capable to confirm written consent prior to enrolment after ample information was given are eligible for the study.
排除标准
- •In Study Part B patients with hemoglobin less 7 mg/dl or less 10 mg/dl including serious symptoms of anemia such as increased heart rate, shortness of breath, dizziness, weakness etc.
- •The hemoglobin value must not be 10 days or older.
结局指标
主要结局
Pharmacokinetic Outcome Measures (e.g., Cmax, AUC)
时间窗: within four weeks after administration of drug of interest
These assessments rely on multiple measurements over time and the Time Frame may include multiple time points describing the interval at which data are collected
次要结局
未报告次要终点
研究者
Ali Mohammad Nejad Sigaroudi
Medical Doctor
University of Cologne