Determination of Drugs and Their Metabolites in Hospitalized Patients

Neoplasms Clinical Trial

Official title:

Determination of Drugs and Their Metabolites in Hospitalized Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01702545
• Other study ID #: PEAK-001
• Status: Recruiting
• Start date: August 2012
• Est. completion date: December 2021

Study information

• Verified date: September 2020
• Source: Klinikum Nürnberg
• Contact: Martin Wilhelm, Prof. Dr.
• Phone: 00499113983050
• Email: martin.wilhelm[@]klinikum-nuernberg.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• legal capacity

Exclusion Criteria:

• severe anemia

Related Conditions & MeSH terms

• Neoplasms

Locations

Country	Name	City	State
Germany	Dept. of Internal Medicine V, Klinikum Nürnberg Nord	Nürnberg	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Klinikum Nürnberg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentrations [ng/mL] of various drugs at different timepoints		up to five years