Ethanol Lock for Prevention of Central Line-Associated Blood Stream Infections

Not Applicable

• Conditions: Central Lines in ICU Patients
• Interventions: Other: Normal Saline; Other: Ethanol 70% pharmaceutical grade

• Registration Number: NCT01344590
• Lead Sponsor: University of Virginia

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2011-02
• Status Verified: 2011-04
• Study First Submitted: 2011-04-27
• Study First Submitted QC: 2011-04-27
• Last Update Submitted: 2011-04-27
• Study First Posted: 2011-04-29
• Last Update Posted: 2011-04-29
• Primary Completion: 2012-05
• Study Completion: 2012-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
saline lock maintenance	Normal Saline	Standard saline lock maintenance
ethanol maintenance	Ethanol 70% pharmaceutical grade	Instillation of 70% pharmaceutical grade ethanol solution into the central line in a volume calculated to fill the catheter lumen and hub.

Primary Outcome Measures

Name	Time	Method
Number of beds using ethanol treatment	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.

Trial Locations

Locations (1)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States