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| Sponsors and Collaborators: |
Erasmus Medical Center Stichting Nuts Ohra |
|---|---|
| Information provided by: | Erasmus Medical Center |
| ClinicalTrials.gov Identifier: | NCT00122642 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Bacteremia |
Procedure: Alcohol-lock Drug: placebo-lock |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Short Daily Alcohol Locks for the Prevention of Tunneled Catheter Infection in Patients With Haematological Disease. Randomised Placebo Controlled Trial |
| Estimated Enrollment: | 440 |
| Study Start Date: | August 2005 |
| Estimated Study Completion Date: | December 2008 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
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 for patients not in the hospital.
|
Procedure: Alcohol-lock
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.
|
|
2: Placebo Comparator
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.
|
Drug: placebo-lock
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.
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Netherlands | |
| Erasmus Medical Center | Recruiting |
| Rotterdam, Netherlands, 3000 CA | |
| Contact: Bart J Rijnders, PhD 31104639222 ext 35339 b.rijnders@erasmusmc.nl | |
| Principal Investigator: | Bart JA Rijnders, MD, PhD | Erasmus Medical Center |
More Information
| Responsible Party: | Rijnders ( BJ ) |
| Study ID Numbers: | AL-01, SNO-T-07-57 |
| Study First Received: | July 19, 2005 |
| Last Updated: | June 11, 2008 |
| ClinicalTrials.gov Identifier: | NCT00122642 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
|
catheterization Catheters, Indwelling |
|
Systemic Inflammatory Response Syndrome Bacterial Infections Sepsis Hematologic Diseases |
Bacteremia Ethanol Inflammation |
|
Pathologic Processes Infection |
