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

Fungal Infection Clinical Trial

Official title:

Evaluation of Sulfobutylether-ß-cyclodextrin Sodium (SBECD) Accumulation and Voriconazole Pharmacokinetics in Patients Undergoing Continuous Renal Replacement Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01101386
• Other study ID #: 10-0136
• Status: Completed
• Phase: Phase 4
• First received: April 6, 2010
• Last updated: May 20, 2014
• Start date: May 2010
• Est. completion date: November 2012

Study information

• Verified date: May 2014
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fungal Infection
• Mycoses

Intervention

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

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine SBECD plasma and effluent concentrations	Evaluate SBECD pharmacokinetics (Cmax, Cmin, AUC, half-life, CL, seiving coefficient). Predict time to SBECD accumulation in study patients	Days 1-7	Yes
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		Days 1-30	Yes
Secondary	Determine Voriconazole and UK121-265 plasma and effluent concentrations	Voriconazole and UK121-265 Pharmacokinetics will be evaluated (Cmax, Cmin, AUC, elimination rate constant, half-life, CL, seiving coefficient) including determination and impact of any CYP2C19 mutations on plasma pharmacokinetic parameters	Days 1-7	No