Clinical trial NCT00122642: Alcohol Locks for the Prevention of Tunneled Catheter-related Infections
Official title: Short Daily Alcohol Locks for the Prevention of Tunneled Catheter Infection in Patients With Haematological Disease. Randomised Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Bacteremia
Keywords: catheterization
Catheters, Indwelling
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Stichting Nuts Ohra
First posted: 2005-07-22
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: In modern-day medicine, the use of intravascular catheters has become unavoidable. In the United States, hospitals and clinics purchase more than 150 million intravascular devices each year of which more than 5 million are central venous catheters. However, their use does not come without risk. It puts patients in danger of mechanical, thrombotic and 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. The increase in expenses was estimated to be 15,965 US dollars per patient with a CRBSI in 1994 and even 56,167 US dollars in another more recent study.

It is clear that the prevention of CRI is of utmost importance and will help to decrease patient suffering as well as cost of patient management. Extensive and detailed evidence-based recommendations for the prevention of CRI were recently published. However, many topics remain unresolved and there still is an urgent need for effective, cheap and easy to implement preventive measures that are without risk of developing antibiotic resistance.

Catheters can become colonized with microorganisms through exoluminal (catheter insertion site) or endoluminal (hub and infusates) routes. It has been shown that, the longer a catheter remains in place, the more important the endoluminal route becomes. The 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 in such a lock for infection prevention should remain exceptional. Although there is evidence to support the concept, methodologically appropriate clinical data on the use of antiseptic solutions for this purpose are still awaited.

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.

Eligibility criteria: Inclusion Criteria:

* Patient at least 18 years old
* Admitted to the haematology department
* Had a tunnelled central venous catheter inserted in the preceding 72 hours

Exclusion Criteria:

* Known allergy to alcohol or active use of metronidazole (or related 2-nitroimidazole compounds) or disulfiram (Antabuse)

Primary outcomes:
measure: Endoluminal catheter related bacteremia
timeFrame: at time of catheter removal
Secondary outcomes:
measure: All catheter-related bacteremias with differential time to positivity (DTTP) > 2 hours
timeFrame: at time of catheter removal
measure: Catheter survival time
timeFrame: at time of catheter removal
measure: Vancomycin and linezolid use
timeFrame: at time of catheter removal
measure: Incidence of positive catheter tip cultures
timeFrame: at time of catheter removal
measure: Incidence of bacteremia/fungemia (catheter-related or not)
timeFrame: at time of catheter removal
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
Study officials:
affiliation: Erasmus Medical Center
name: Bart JA Rijnders, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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