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Quantification of Drugs and Their Degradation Products

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01828372
Recruitment Status : Unknown
Verified April 2013 by Ali Mohammad Nejad Sigaroudi, University of Cologne.
Recruitment status was:  Not yet recruiting
First Posted : April 10, 2013
Last Update Posted : April 10, 2013
Sponsor:
Information provided by (Responsible Party):
Ali Mohammad Nejad Sigaroudi, University of Cologne

Brief Summary:

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).


Condition or disease Intervention/treatment Phase
Liver Insufficiency Kidney Failure, Chronic Obesity Pregnancy Breast Feeding, Exclusive Sepsis Multiple Organ Failure Other: additional blood withdrawals Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Quantification of Drugs and Their Metabolites in Patients at the Cologne University Hospital
Study Start Date : May 2013
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : March 2017

Arm Intervention/treatment
additional blood withdrawals
Theoretical anyone with taking a drug of interest (see "list of substances and metabolites of interest") can join this trial. But we turn mainly our attention to patient groups who are excluded in modern drug approval studies.
Other: additional blood withdrawals
Blood withdrawals by either venous puncture or placement of permanent venous catheter.




Primary Outcome Measures :
  1. Pharmacokinetic Outcome Measures (e.g., Cmax, AUC) [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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): NCT01828372


Contacts
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Contact: Uwe Fuhr, Professor 0049-221-478 ext 5230 uwe.fuhr@uk-koeln.de

Locations
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Germany
Department of Pharmacology, Cologne University Hospital
Cologne, NRW, Germany, 50937
Contact: Uwe Fuhr, Professor       uwe.fuhr@uk-koeln.de   
Sub-Investigator: Ali Mohammad Nejad Sigaroudi, M.D.         
Sponsors and Collaborators
University of Cologne
Investigators
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Study Director: Uwe Fuhr, Professor Department of Pharmacology
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Responsible Party: Ali Mohammad Nejad Sigaroudi, Medical Doctor, University of Cologne
ClinicalTrials.gov Identifier: NCT01828372    
Other Study ID Numbers: KPUK-12-GenPOPPK-2
2013-000779-33 ( EudraCT Number )
First Posted: April 10, 2013    Key Record Dates
Last Update Posted: April 10, 2013
Last Verified: April 2013
Keywords provided by Ali Mohammad Nejad Sigaroudi, University of Cologne:
concomitant diseases
multiple drug consumption
therapeutic drug monitoring
TDM
drug monitoring
drug level
quantification
drug
drug concentration
concentration
therapeutic range
therapeutic index
Additional relevant MeSH terms:
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Hepatic Insufficiency
Liver Failure
Renal Insufficiency
Kidney Failure, Chronic
Multiple Organ Failure
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Shock
Pathologic Processes
Liver Diseases
Digestive System Diseases