Study of Cyclodextrin (SBECD) and Voriconazole Blood Concentrations During Continuous Dialysis

Completed

Conditions studied: Fungal Infection

In brief

This study's primary objective is to determine if continuous renal replacement therapy (CRRT) can adequately remove the sulfobutylether-ß-cyclodextrin sodium (SBECD) vehicle from the blood so that intravenous voriconazole can be utilized in critically ill patients with renal dysfunction requiring dialysis. Secondarily, the pharmacokinetics of intravenous voriconazole and its metabolite (UK121-265) and adverse effects of SBECD accumulation will also be evaluated. The study hypothesis is that CRRT is effective at removing SBECD and allows patients to receive intravenous voriconazole without the concern of SBECD accumulation.

Key facts

Study ID

NCT01101386

Run by

University of Colorado, Denver

People needed

10

Starts

2010-05-01

Expected to finish

2012-11-01

Last updated by the study team

2014-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who are receiving continuous renal replacement therapy and are prescribed voriconazole therapy for the treatment or prophylaxis of a fungal infection.

You may not qualify if…

• Patients expected to be on CRRT for < 5 days,
• Patients with Child-Pugh C cirrhosis, and
• Patients who are pregnant.

Where it is running

• University of Colorado Hospital — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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