Recruiting

Ethanol Lock

Sponsor:

University of Virginia

Code:

NCT01344590

Conditions

Central Lines in ICU Patients

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Normal Saline

Ethanol 70% pharmaceutical grade

Study Details

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.

Conditions

Central Lines in ICU Patients

Study ID

NCT01344590

Start date

Feb, 2011

Status verified date

Apr, 2011

Completion date

May, 2012

Anticipated

Primary completion date

May, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Interventions and Outcome Measures

Arms

active comparator: saline lock maintenance

Standard saline lock maintenance

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.

Interventions

Normal Saline

Standard saline procedure will be utilized.

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.

Primary outcome measure

  • Number of beds using ethanol treatment [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Ron Turner, MD

434-243-9864rbt2n@virginia.edu

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Donna Weakley-Marion

434-924-2169dw4c@virginia.edu

Principal Investigator:

Ron Turner, MD

More Information

Sponsor

University of Virginia

Last update posted

Apr 29, 2011

Last verified

Apr, 2011

Keywords

  • central line associated blood stream infections

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2011-04-29.