Ethanol Lock for Prevention of Central Line-Associated Blood Stream Infections
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 27, 2011
CompletedFirst Posted
Study publicly available on registry
April 29, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedApril 29, 2011
April 1, 2011
1.2 years
April 27, 2011
April 27, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of beds using ethanol treatment
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
Study Arms (2)
saline lock maintenance
ACTIVE COMPARATORStandard saline lock maintenance
ethanol maintenance
EXPERIMENTALInstillation of 70% pharmaceutical grade ethanol solution into the central line in a volume calculated to fill the catheter lumen and hub.
Interventions
70% pharmaceutical grade ethanol will be instilled in the line in a volume calculated to fill the lumen and the hub.
Eligibility Criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Virginia
Charlottesville, Virginia, 22903, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ron Turner, MD
University of Virginia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 27, 2011
First Posted
April 29, 2011
Study Start
February 1, 2011
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
April 29, 2011
Record last verified: 2011-04