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Determination of Drugs and Their Metabolites in Hospitalized Patients

This study is currently recruiting participants.
Verified March 2017 by Mr. Prof. Dr. Wilhelm, Klinikum Nürnberg
Sponsor:
ClinicalTrials.gov Identifier:
NCT01702545
First Posted: October 8, 2012
Last Update Posted: March 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Mr. Prof. Dr. Wilhelm, Klinikum Nürnberg
  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
Official Title: Determination of Drugs and Their Metabolites in Hospitalized Patients

Further study details as provided by Mr. Prof. Dr. Wilhelm, Klinikum Nürnberg:

Primary Outcome Measures:
  • Plasma concentrations [ng/mL] of various drugs at different timepoints [ Time Frame: up to five years ]

Biospecimen Description:
Blood, Plasma

Estimated Enrollment: 1000
Study Start Date: August 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01702545


Contacts
Contact: Martin Wilhelm, Prof. Dr. 00499113983050 martin.wilhelm@klinikum-nuernberg.de
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
Investigators
Study Chair: Martin Wilhelm, Prof Dr. Paracelsus Medical University Klinikum Nuremberg, Germany
  More Information

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
First Submitted: October 1, 2012
First Posted: October 8, 2012
Last Update Posted: March 9, 2017
Last Verified: March 2017