Study of Cyclodextrin (SBECD) and Voriconazole Blood Concentrations During Continuous Dialysis
Evaluation of Sulfobutylether-ß-cyclodextrin Sodium (SBECD) Accumulation and Voriconazole Pharmacokinetics in Patients Undergoing Continuous Renal Replacement Therapy
1 other identifier
observational
10
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2010
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 6, 2010
CompletedFirst Posted
Study publicly available on registry
April 9, 2010
CompletedStudy Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedMay 22, 2014
May 1, 2014
2.5 years
April 6, 2010
May 20, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Days 1-30
Determine Voriconazole and UK121-265 plasma and effluent concentrations
Days 1-7
Study Arms (1)
Voriconazole
Pharmacokinetic Monitoring
Interventions
Patients will be started on voriconazole 6 mg/kg IV q12h on day 1, then 4 mg/kg IV q12h thereafter.
Eligibility Criteria
Hospitalized patients
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Colorado Hospital
Aurora, Colorado, 80045, United States
Related Publications (1)
Kiser TH, Fish DN, Aquilante CL, Rower JE, Wempe MF, MacLaren R, Teitelbaum I. Evaluation of sulfobutylether-beta-cyclodextrin (SBECD) accumulation and voriconazole pharmacokinetics in critically ill patients undergoing continuous renal replacement therapy. Crit Care. 2015 Feb 3;19(1):32. doi: 10.1186/s13054-015-0753-8.
PMID: 25645660DERIVED
Biospecimen
Whole blood, serum, urine, effluent fluid from dialysis machine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ty H Kiser, PharmD
Univesity of Colorado Anschutz Medical Campus
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 6, 2010
First Posted
April 9, 2010
Study Start
May 1, 2010
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
May 22, 2014
Record last verified: 2014-05