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Clinical Trials/NCT01812473
NCT01812473CompletedNot Applicable

Impact of Hypoalbuminemia on Voriconazole Pharmacokinetics in Critically Ill Adult Patients.

Universitaire Ziekenhuizen KU Leuven1 site in 1 country35 target enrollmentStarted: February 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
35
Locations
1
Primary Endpoint
Differences in Overall Protein Binding in the Presence of Different Plasma Albumin Concentrations.

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
2 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • treated with voriconazole

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Differences in Overall Protein Binding in the Presence of Different Plasma Albumin Concentrations.

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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