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NCT01101386 · ClinicalTrials.gov registry record

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

A clinical trial of Fungal Infection, sponsored by University of Colorado, Denver.

Completed
Registry status
10
Enrollment target
1
Study location

NCT01101386: Completed study of Fungal Infection, sponsored by University of Colorado, Denver.

NCT01101386 is a study of Fungal Infection that has completed, run by University of Colorado, Denver. The registered enrollment target is 10 participants, below the 161-participant average among 6 other Fungal Infection trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01101386, a study of Fungal Infection, has completed, sponsored by University of Colorado, Denver.

COMPLETED
Registry status
10 participants
Enrollment target
1
Study location

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.

Primary Outcome

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

Conditions Studied

Interventions

  • DRUG Voriconazole

Study Locations (1)

Colorado

  • University of Colorado Hospital - Aurora

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2010-05
Est. Completion 2012-11
University of Colorado, Denver

1,283 total trials

What the finished NCT01101386 record still lists

NCT01101386 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 161-participant average among 6 other Fungal Infection trials with a reported enrollment target (94% lower).

The record links to 1 condition, with Fungal Infection appearing as the primary indexed condition, and to 1 intervention - of which Voriconazole is the first listed.

NCT01101386 reports a single indexed study location in Colorado.

Frequently Asked Questions

What is clinical trial NCT01101386 about?

NCT01101386 is a clinical study titled "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 di...

What is the current status of trial NCT01101386?

This trial is currently completed. The enrollment target is 10 participants. The study started on 2010-05. Estimated completion is 2012-11.

What conditions does trial NCT01101386 study?

This clinical trial studies the following conditions: Fungal Infection.

What interventions are being tested in trial NCT01101386?

The interventions under investigation include: Voriconazole (DRUG).

Who is sponsoring clinical trial NCT01101386?

This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01101386 being conducted?

This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT01101386, the US trial registry maintained by the National Library of Medicine. NCT01101386 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.