Quantification of Drugs and Their Degradation Products

NCT01828372 | Unknown DMC

• 2 other identifiers: KPUK-12-GenPOPPK-22013-000779-33
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

concomitant diseases; multiple drug consumption; therapeutic drug monitoring; TDM; drug monitoring; drug level; quantification; drug; drug concentration; concentration; therapeutic range; therapeutic index

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic Outcome Measures (e.g., Cmax, AUC)

  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

  within four weeks after administration of drug of interest

Study Arms (1)

additional blood withdrawals

OTHER

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

Interventions

additional blood withdrawals OTHER

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

additional blood withdrawals

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (1)

Department of Pharmacology, Cologne University Hospital

Cologne, North Rhine-Westphalia, 50937, Germany

Location

MeSH Terms

Conditions

Hepatic Insufficiency; Kidney Failure, Chronic; Obesity; Breast Feeding; Sepsis; Multiple Organ Failure

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Feeding Behavior; Behavior; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Shock

Study Officials

• Uwe Fuhr, Professor

  Department of Pharmacology

  STUDY DIRECTOR

Central Study Contacts

Uwe Fuhr, Professor

CONTACT

0049-221-478; uwe.fuhr@uk-koeln.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: March 14, 2013
• First Posted: April 10, 2013
• Study Start: May 1, 2013
• Primary Completion: April 1, 2016
• Study Completion: March 1, 2017
• Last Updated: April 10, 2013

Record last verified: 2013-04

Locations

DE (1)