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

April 27, 2011 updated by: University of Virginia

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Recruiting
        • University of Virginia
        • Contact:
        • Principal Investigator:
          • Ron Turner, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Investigators

  • Principal Investigator: Ron Turner, MD, University of Virginia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Anticipated)

May 1, 2012

Study Completion (Anticipated)

May 1, 2012

Study Registration Dates

First Submitted

April 27, 2011

First Submitted That Met QC Criteria

April 27, 2011

First Posted (Estimate)

April 29, 2011

Study Record Updates

Last Update Posted (Estimate)

April 29, 2011

Last Update Submitted That Met QC Criteria

April 27, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15397

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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