Study of Cyclodextrin (SBECD) and Voriconazole Blood Concentrations During Continuous Dialysis
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/11/2012 |
| Start Date: | May 2010 |
| End Date: | December 2012 |
Evaluation of Sulfobutylether-ß-cyclodextrin Sodium (SBECD) Accumulation and Voriconazole Pharmacokinetics in Patients Undergoing Continuous Renal Replacement Therapy
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.
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.
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