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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Voriconazole | Pharmacokinetic Monitoring |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Voriconazole | Drug | Patients will be started on voriconazole 6 mg/kg IV q12h on day 1, then 4 mg/kg IV q12h thereafter. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Hospitalized patients
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| Name | Affiliation | Role |
|---|---|---|
| Ty H Kiser, PharmD | Univesity of Colorado Anschutz Medical Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Hospital | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25645660 | Derived | 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. |
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| ID | Term |
|---|---|
| D009181 | Mycoses |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D065819 | Voriconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Whole blood, serum, urine, effluent fluid from dialysis machine
| Days 1-7 |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |