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

NCT01101386 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2014-05-22

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Voriconazole

Patients will be started on voriconazole 6 mg/kg IV q12h on day 1, then 4 mg/kg IV q12h thereafter.

Sponsors & Collaborators

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Ty H Kiser, PharmD · Univesity of Colorado Anschutz Medical Campus

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01101386 on ClinicalTrials.gov