Plasma Protein Binding Characteristics of Voriconazole

Completed

• Conditions: Focus of the Study:Protein Binding Characteristics of Voriconazole.
• Interventions: Other: Blood sampling

• Registration Number: NCT01812473
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

The purpose of this study is to investigate the influence of hypoalbuminemia on the protein binding characteristics of the antifungal drug voriconazole in ICU patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Status Verified: 2013-03
• Study First Submitted: 2013-03-01
• Study First Submitted QC: 2013-03-13
• Study First Posted: 2013-03-18
• Primary Completion: 2013-06
• Study Completion: 2013-12
• Results First Submitted: 2015-01-13
• Results First Submitted QC: 2015-01-30
• Results First Posted: 2015-02-18
• Last Update Submitted: 2015-03-03
• Last Update Posted: 2015-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• treated with voriconazole

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients admitted to the Intensive Care Unit	Blood sampling	All patients admitted to the Intensive Care Unit, treated with voriconazole are eligible for the study.

Primary Outcome Measures

Name	Time	Method
Differences in Overall Protein Binding in the Presence of Different Plasma Albumin Concentrations.	At steady state plasma concentration of voriconazole (after day 4 of therapy)	At steady state plasma concentrations of voriconazole, a plasma sample is taken to determine the overall protein binding of voriconazole. Equilibrium dialysis is used, followed by liquid chromatography-mass spectrometry.

Trial Locations

Locations (1)

University Hospitals Leuven; 🇧🇪 Leuven, Vlaams-Brabant, Belgium