Determination of Drugs and Their Metabolites in Hospitalized Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Klinikum Nürnberg
Sponsor:
Information provided by (Responsible Party):
Mr. Prof. Dr. Wilhelm, Klinikum Nürnberg
ClinicalTrials.gov Identifier:
NCT01702545
First received: October 1, 2012
Last updated: November 21, 2013
Last verified: November 2013
  Purpose

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.


Condition
Neoplasms

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Further study details as provided by Klinikum Nürnberg:

Primary Outcome Measures:
  • Plasma concentrations [ng/mL] of various drugs at different timepoints

Biospecimen Description:

Blood, Plasma


Estimated Enrollment: 1000
Study Start Date: August 2012
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Hospitalized patients

Criteria

Inclusion Criteria:

  • legal capacity

Exclusion Criteria:

  • severe anemia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01702545

Contacts
Contact: Martin Wilhelm, Prof. Dr. 00499113983050 martin.wilhelm@klinikum-nuernberg.de

Locations
Germany
Dept. of Internal Medicine V, Klinikum Nürnberg Nord Recruiting
Nürnberg, Bavaria, Germany, 90419
Contact: Martin Wilhelm, Prof. Dr.    00499113983050    martin.wilhelm@klinikum-nuernberg.de   
Principal Investigator: Martin Wilhelm, Prof. Dr.         
Sponsors and Collaborators
Klinikum Nürnberg
  More Information

No publications provided

Responsible Party: Mr. Prof. Dr. Wilhelm, Prof. Dr. med. Martin Wilhelm, Klinikum Nürnberg
ClinicalTrials.gov Identifier: NCT01702545     History of Changes
Other Study ID Numbers: PEAK-001
Study First Received: October 1, 2012
Last Updated: November 21, 2013
Health Authority: Germany: University Hospital Erlangen

ClinicalTrials.gov processed this record on September 18, 2014