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Completed

NCT Number: NCT01101386

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

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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Key information

Conditions

Fungal Infection Bacterial Infections and Mycoses Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Kidney Diseases Male Urogenital Diseases Mycoses Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Voriconazole

Drug

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

Other names: Vfend

Primary outcomes

  1. Determine SBECD plasma and effluent concentrations

    Time frame: Days 1-7

    Evaluate SBECD pharmacokinetics (Cmax, Cmin, AUC, half-life, CL, seiving coefficient). Predict time to SBECD accumulation in study patients

Secondary outcomes

  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Time frame: Days 1-30

  2. Determine Voriconazole and UK121-265 plasma and effluent concentrations

    Time frame: Days 1-7

    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

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Apr 9, 2010
Registry last updated
May 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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