Antibiotic Lock Solutions in the Prevention of Catheter Related Bacteremia
|First Received Date ICMJE||February 21, 2006|
|Last Updated Date||February 21, 2006|
|Start Date ICMJE||September 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Incidence of symptomatic CRB|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Antibiotic Lock Solutions in the Prevention of Catheter Related Bacteremia|
|Official Title ICMJE||Not Provided|
To study the efficacy of an antibacterial/anticoagulant solution instilled into the hemodialysis (HD) catheters after each treatment (“antibiotic lock solution - ALS”) to prevent catheter related bacteremia (CRB) and to salvage catheters with established CRB.
Scope of the problem. A large number of hemodialysis patients in this country rely on indwelling tunneled and non-tunneled catheters as vascular access for hemodialysis even though the K/DOQI guidelines discourage their use. In a study performed by ESRD network 11, [to which all Michigan dialysis centers submit data] 63% of patients initiated HD with a catheter as their sole form of vascular access. At 6 months after initiation of HD, 40% of these patients were still using a catheter. Other studies had shown that the prevalence of overall catheter use to be around 20% of all accesses.
Catheter associated infection. Current literature indicates that these catheters are associated with a disproportionate risk for infection, particularly CRB, resulting in high morbidity, mortality and healthcare expenditure. The ‘epidemic’ of ESRD in this country has seen an ever increasing reliance on these catheters not only to initiate the HD but also for long term treatment in those patients who have no other access options. It has been estimated that intravascular catheters are associated with more than 60,000 cases of nosocomial bacteremia each year. HD catheters pose a particularly high risk for developing infections because of their frequent use as well as their long-term use. All indwelling vascular catheters are colonized by micro-organisms within 24 hours after insertion. The deposition of biofilm on the external and internal surface of vascular catheters is thought to play an important role in the colonization process. The biofilm is produced by a combination of host factors (e.g., fibrinogen, fibrin, fibronectin and extracellular polysaccharides) and microbial products (e.g., glycocalyx or "slime").
Failure of antibiotics. Systemic antibiotics used to treat bacteremia do not penetrate catheter lumen and therefore do not eradicate the biofilm, leading to potential treatment failures and eventual sacrifice of the catheter. Recently published data suggests that using a combination solution with antibacterial/anticoagulant agents prevents the formation of the ‘biofilm’ in the catheter lumen thereby preventing CRB, as well as salvage the catheters in cases of established CRB. However, there continues to be a debate on the appropriate antibacterial agent as well as its optimal concentration, in order to eradicate a wide variety of organisms. Several other strategies were studied in the past 10 years to prevent CRB and CRI. These include eradication of nasal Staphylococcal carriage with mupirocin, using chlorhexidine for catheter hub cleaning and exit site disinfection and using mupirocin or Polysporin ointments to the exit site along with standard dressing. But emergence of antibiotic resistance as well as the high costs of administrating these methods continue to be barriers to their widespread use and cannot be relied upon to manage the high rate of infection by themselves.
Salvaging catheters. In the past, infected catheters were routinely removed, especially for Staphylococcus aureus infections, per the CDC guidelines. However, recent small studies indicate that strategies such as ALS packing or changing catheter over a guide wire can salvage a significant fraction of these catheters, thereby saving expense and morbidity, and preserving the site. Thrombotic occlusions and infection are the two most common complications of the HD catheters, each predisposing to the other. Some studies have shown that ALS packing has also improved the long-term catheter function by preventing the formation and propagation of the biofilm. Studying this aspect of catheter maintenance is also an important outcome for our proposed study.
Antibiotic Lock Solutions. We have identified 10 clinical trials (attached as appendix) in the published literature describing the results of antibiotic lock therapy for preventing infections in indwelling vascular catheters. All but one have demonstrated efficacy of ALS packing. Of the 9 successful trials, only 6 were randomized controlled trials and only 3 of these were done on HD catheters, as described below.
Need for a prospective study. If we can achieve the same superior results from our study incorporating the ALS packing strategy, we should be able to assess cost- effectiveness of using the ALS packing vs. standard approach as has been discussed in previous trials, but has not been systematically studied. In fact there are insufficient numbers of patients studies to even perform a meta-analysis. We feel that it is critical to prove the cost-effectiveness of the new strategy in order for it to be used in a widespread fashion.
The applicant, Anatole Besarab MD, has extensive experience in Nephrology and specifically in vascular access management. He has published, lectured, and coordinated symposia on vascular access care and is the current chair of the K/DOQI vascular access workgroup of the NKF.
This project is conceived for the following reasons.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 4|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Intervention ICMJE||Drug: Gentamycin/citrate, Minocycline/EDTA|
|Study Arm (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||May 2004|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 75 Years|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00294502|
|Other Study ID Numbers ICMJE||3008|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Henry Ford Health System|
|Collaborators ICMJE||Not Provided|
|Information Provided By||Henry Ford Health System|
|Verification Date||September 2003|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP