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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by University of Virginia.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Virginia
ClinicalTrials.gov Identifier:
NCT01344590
First received: April 27, 2011
Last updated: NA
Last verified: April 2011
History: No changes posted
  Purpose

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 Intervention
Central Lines in ICU Patients
Other: Normal Saline
Other: Ethanol 70% pharmaceutical grade

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Ethanol Lock for Prevention of Central Line-Associated Blood Stream Infections

Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Number of beds using ethanol treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: February 2011
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01344590

Contacts
Contact: Ron Turner, MD 434-243-9864 rbt2n@virginia.edu

Locations
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Donna Weakley-Marion    434-924-2169    dw4c@virginia.edu   
Principal Investigator: Ron Turner, MD         
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: Ron Turner, MD University of Virginia
  More Information

No publications provided

Responsible Party: Ronald Truner, MD, University of Virginia
ClinicalTrials.gov Identifier: NCT01344590     History of Changes
Other Study ID Numbers: 15397
Study First Received: April 27, 2011
Last Updated: April 27, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Virginia:
central line associated blood stream infections

Additional relevant MeSH terms:
Infection
Ethanol
Anti-Infective Agents
Anti-Infective Agents, Local
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014