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

NCT ID: NCT01344590

Last Updated: 2011-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-05-31

Brief Summary

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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

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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.

Conditions

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Central Lines in ICU Patients

Keywords

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central line associated blood stream infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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saline lock maintenance

Standard saline lock maintenance

Group Type ACTIVE_COMPARATOR

Normal Saline

Intervention Type OTHER

Standard saline procedure will be utilized.

ethanol maintenance

Instillation of 70% pharmaceutical grade ethanol solution into the central line in a volume calculated to fill the catheter lumen and hub.

Group Type EXPERIMENTAL

Ethanol 70% pharmaceutical grade

Intervention Type OTHER

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

Interventions

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Normal Saline

Standard saline procedure will be utilized.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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Exclusion Criteria

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Virginia

OTHER

Sponsor Role lead

Responsible Party

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University of Virginia

Principal Investigators

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Ron Turner, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

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University of Virginia

Charlottesville, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ron Turner, MD

Role: CONTACT

Phone: 434-243-9864

Email: [email protected]

Facility Contacts

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Donna Weakley-Marion

Role: primary

Other Identifiers

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15397

Identifier Type: -

Identifier Source: org_study_id