Skip to content

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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01344590
Enrollment
50
Registered
2011-04-29
Start date
2011-02-28
Completion date
2012-05-31
Last updated
2011-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Lines in ICU Patients

Keywords

central line associated blood stream infections

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.

Interventions

OTHERNormal Saline

Standard saline procedure will be utilized.

OTHEREthanol 70% pharmaceutical grade

70% pharmaceutical grade ethanol will be instilled in the line in a volume calculated to fill the lumen and the hub.

Sponsors

University of Virginia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

Although this study is done in the patient-care setting, patients are not the subject of the study. The outcome of interest involves the development of CLABSI in patients but the intervention is directed at the patient's central lines rather than the patient. There are no inclusion or

Exclusion criteria

; the determination of the line care regimen will be determined by the bed assignment rather than any characteristics of the patient occupying the bed. All central line will be included in this study. Use of ethanol will be suspended whenever the usage of the line precludes instillation of ethanol with a dwell time of al least one hour.

Design outcomes

Primary

MeasureTime frameDescription
Number of beds using ethanol treatment12 monthsThe 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.

Countries

United States

Contacts

Primary ContactRon Turner, MD
rbt2n@virginia.edu434-243-9864

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026