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

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Fungal Infection

Treatments: Drug: Voriconazole

Study type: Observational

Funder types: Other

Identifiers

NCT01101386

10-0136

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

10 participants in 1 patient group

Voriconazole

Description:

Pharmacokinetic Monitoring

Treatment:

Drug: Voriconazole