CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 440 target
Drug / intervention
placebo-lock +1 moredrug
Likely dose
Not stated in 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/NCT00122642
NCT00122642Phase 3Completed

Short Daily Alcohol Locks for the Prevention of Tunneled Catheter Infection in Patients With Haematological Disease. Randomised Placebo Controlled Trial

Erasmus Medical Center·interventional·Posted Jul 22, 2005·Updated Sep 25, 2009

In Brief

A Phase 3 clinical trial evaluating Alcohol-lock and placebo-lock for Bacteremia. Completed, enrolled 440 participants across 1 site.

Detailed Summary

In modern-day medicine, the use of central venous catheters has become unavoidable. However, their use does not come without risk. It puts patients in danger of infectious complications (catheter-related infections \[CRI\]), the most important of which is catheter-related bloodstream infection (CRBSI). CRBSI is associated with a significant increase in hospital stay and, therefore, cost of patient management, morbidity, and probably also mortality. There still is an urgent need for effective, cheap and easy to implement measures to prevent CRI that are without risk of developing antibiotic resistance. During use, bacteria can colonize the inner surface of the catheter. This endoluminal route of infection can be prevented to some extent when an antibiotic solution is instilled in the catheter for a long enough time and on a regular basis. However, to avoid resistance from occurring, the use of antibiotics for infection prevention should remain exceptional. The use of a non-toxic antiseptic might be a better alternative. Recently, the use of an alcohol lock solution was suggested as a promising way to prevent CRBSI and the compatibility of polyurethane and silicone catheters submerged in an alcohol solution was publicized with no biomechanical or structural changes detected after 9 weeks of immersion. The major advantage of an alcohol lock solution would be the broad antimicrobial spectrum without the risk of compromising future antibiotic treatment as, in contrast to the use of an antibiotic lock, the development of antibiotic resistance is not of concern. Furthermore it would be cheap and universally available. In this randomised study, the efficacy of a 70% alcohol lock solution for the prevention of CRBSI will be compared with placebo when applied for 15 minutes per day.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBacteremia
CountriesNetherlands
CollaboratorsStichting Nuts Ohra

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 22, 2005
Enrollment StartAug 1, 2005
Primary CompletionJun 1, 2009
Study CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 20.9 years ago

Interventions

Alcohol-lockprocedure

The intervention is the instillation of ethanol 70% solution in the catheter lumen (or lumina) for 15minutes per day during hospital stay and for 15minutes per week for patients not in the hospital.

placebo-lockdrug

The intervention is the instillation of placebo solution in the catheter lumen (or lumina) for 15minutes per day during hospital stay and for 15minutes per week for patients not in the hospital.