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Quantification of Drugs and Their Degradation Products

NCT01828372 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2013-04-10

No results posted yet for this study

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).

Conditions

  • Liver Insufficiency
  • Kidney Failure, Chronic
  • Obesity
  • Pregnancy
  • Breast Feeding, Exclusive
  • Sepsis
  • Multiple Organ Failure

Interventions

OTHER

additional blood withdrawals

Blood withdrawals by either venous puncture or placement of permanent venous catheter.

Sponsors & Collaborators

  • University of Cologne

    lead OTHER

Principal Investigators

  • Uwe Fuhr, Professor · Department of Pharmacology

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2016-04-30
Completion
2017-03-31

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01828372 on ClinicalTrials.gov