Ethanol Lock for Prevention of Central Line-Associated Blood Stream Infections
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|ClinicalTrials.gov Identifier: NCT01344590|
Recruitment Status : Unknown
Verified April 2011 by University of Virginia.
Recruitment status was: Recruiting
First Posted : April 29, 2011
Last Update Posted : April 29, 2011
Vascular access via central venous lines (CVL) is essential to the care of many patients in the intensive care setting. While the value of these lines for the management of critically ill patients is generally accepted, the potential for line-associated blood stream infection is a known complication of the use of this intervention.
Ethanol is an effective antimicrobial agent with activity against a broad spectrum of human pathogens.
The purpose of this study is to evaluate the effectiveness of daily treatment of the catheter lumen with ethanol to prevent central line associated blood stream infections (CLABSI). The hypothesis is that this treatment will reduce the incidence of CLABSI compared to maintenance of the lines with normal saline alone.
|Condition or disease||Intervention/treatment|
|Central Lines in ICU Patients||Other: Normal Saline Other: Ethanol 70% pharmaceutical grade|
Blood stream infections are an important complication of the use of central venous lines (CVLs) and result in increased morbidity, mortality, and cost. Blood stream infections related to CVLs may be the result of migration of skin organisms along the catheter tract or introduction of organisms into the lumen of the catheter. The extraluminal route of infection appears to be most common early after catheter insertion while the frequency of infection acquired by the intraluminal route appears to increase the longer the catheter is in place. Meticulous attention to best practices for insertion and the subsequent care of the insertion site reduces infection by the extraluminal route. Adherence to good technique for entering the line may similarly reduce infection by the intraluminal route.
Ethanol is an effective antimicrobial agent with activity against a broad spectrum of human pathogens; including the bacteria and fungi which most commonly infect CVLs. The mechanism of the antimicrobial activity of ethanol is attributed to the ability to denature proteins and induced resistance to the effect of ethanol has not been reported. These features suggest that ethanol-lock is a promising approach to the prevention of acquisition of central line associated blood stream infections by the intraluminal route.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ethanol Lock for Prevention of Central Line-Associated Blood Stream Infections|
|Study Start Date :||February 2011|
|Estimated Primary Completion Date :||May 2012|
|Estimated Study Completion Date :||May 2012|
Active Comparator: saline lock maintenance
Standard saline lock maintenance
Other: Normal Saline
Standard saline procedure will be utilized.
Experimental: ethanol maintenance
Instillation of 70% pharmaceutical grade ethanol solution into the central line in a volume calculated to fill the catheter lumen and hub.
Other: Ethanol 70% pharmaceutical grade
70% pharmaceutical grade ethanol will be instilled in the line in a volume calculated to fill the lumen and the hub.
- Number of beds using ethanol treatment [ Time Frame: 12 months ]The primary endpoint of the study will be the effectiveness of ethanol for prevention of CLABSI compared to routine care. This will be assessed at the end of the study (12 months)by comparing the number of beds being maintained by each regimine to determine if the distribution of line maintenance regimines is non-random in favor of either ethanol lock or saline maintenance.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01344590
|Contact: Ron Turner, MDfirstname.lastname@example.org|
|United States, Virginia|
|University of Virginia||Recruiting|
|Charlottesville, Virginia, United States, 22903|
|Contact: Donna Weakley-Marion 434-924-2169 email@example.com|
|Principal Investigator: Ron Turner, MD|
|Principal Investigator:||Ron Turner, MD||University of Virginia|