CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 16 enrolled
Drug / intervention
25% ethanol +1 moredrug
Likely dose
25% ethanol 2.3 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00948441
NCT00948441N/ACompleted
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Ethanol Lock Therapy for the Prevention of Catheter Related Blood Stream Infections

University of Pittsburgh·interventional·Posted Jul 29, 2009·Updated Apr 18, 2016

In Brief

A clinical study evaluating 25% ethanol and heparin lock for Catheter-Related Infections. Completed, enrolled 16 participants across 1 site.

Detailed Summary

This study is a double-blind crossover design to compare prophylaxis with ethanol lock therapy versus placebo lock therapy (heparin). The primary outcome measure will be the number of catheter related blood stream infections (CRBSI) in each time period.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCatheter-Related Infections
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 29, 2009
Enrollment StartAug 1, 2008
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 16.9 years ago

Interventions

25% ethanoldrug

Study Lock -25% Ethanol- The ethanol lock therapy consists of placing up to 2.3 ml of 25% ethanol into the central venous catheter and allowing it to dwell for 4 to 12 hours per day.

heparin lockother

Placebo Lock - Heparin - These will be prepared in a sterile fashion in the Pharmacy of Children's Hospital of Pittsburgh in 10 day supplies as 1ml lock syringes utilizing 100 units/ml if the central venous catheter is accessed once daily and 10 units/ml if accessed more than once daily. The lock solution will be instilled and allowed to dwell for 4 to 12 hours.