Ethanol Lock for Prevention of Central Line-Associated Blood Stream Infections
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 |
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| Contact: Ron Turner, MD | 434-243-9864 | rbt2n@virginia.edu |
| 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 | |
| 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:
|
Ethanol Anti-Infective Agents, Local Anti-Infective Agents Therapeutic Uses |
Pharmacologic Actions Central Nervous System Depressants Physiological Effects of Drugs Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 23, 2013