Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00122642
Status:
COMPLETED
Last Update Posted:
2009-09-25
First Post:
2005-07-19
Brief Title:
Alcohol Locks for the Prevention of Tunneled Catheter-related Infections
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
Official Title:
Short Daily Alcohol Locks for the Prevention of Tunneled Catheter Infection in Patients With Haematological Disease Randomised Placebo Controlled Trial
Status:
COMPLETED
Status Verified Date:
2009-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 15965 US dollars per patient with a CRBSI in 1994 and even 56167 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SNO-T-07-57 | None | None | None |