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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00965198
Other study ID # IRB00016682
Secondary ID B16682
Status Completed
Phase N/A
First received July 16, 2009
Last updated November 19, 2013
Start date November 2009
Est. completion date July 2011

Study information

Verified date November 2013
Source Emory University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

Intravenous catheters are placed in nearly every hospitalized patient. These catheters, since they are breaks in skin integrity, are potential sources of infection that occur in the bloodstream. Bloodstream infections can result in higher rates of death and lengths of hospital stay, as well as increase healthcare costs. Blood is drawn or medications delivered through a catheter access device attached to the catheter. In looking at new ways to decrease infections associated with healthcare, the investigators plan to test whether the use of a silver-coated catheter access device (VLINK) compared to the standard, non-coated device (CLEARLINK) can reduce infection rates. These devices are identical in design other than the silver coating of the VLINK, that imparts a brown color to the device. Silver can prevent the growth of bacteria inside the device (biofilm formation) in the laboratory, but this has never been proven in patients.

The investigators propose to do a crossover study in two Emory-owned hospitals (Emory University Hospital and Emory University Hospital at Midtown), anticipated to last 10 months. Currently, both types of devices, (standard and silver-coated) are FDA approved for clinical use and are in use at both hospitals. The investigators plan to have each hospital use only one type of catheter access device for a period of time (approximately 5 months), and then switch ("crossover") to other type of device for the rest of the study. All patients admitted to either hospital (excluding newborns and patients with infections attributed to hemodialysis catheters) will be enrolled since both devices meet the standard of care. During the study, the infection prevention department, as a continuing part of their regular duties will measure infection rates. A small subset of catheters that are removed during routine clinical care (none will be taken out solely for the study) will be sent to CDC to determine the amount of bacteria inside catheters and catheter access devices (look for biofilm). Finally, the microbiology lab, again as part of its routine function will determine the rate at which blood cultures are falsely positive. All of these measures will be compared using statistical methods to see if there is a difference between the standard and silver-coated catheter access devices.

In undertaking this study, the investigators will be using a type of vascular access device (valve, not positive pressure) already in use in both hospitals and not changing the delivery of care to patients while, in a rigorous, systematic manner, obtaining samples and data for analysis.


Recruitment information / eligibility

Status Completed
Enrollment 10000
Est. completion date July 2011
Est. primary completion date July 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- All adult patients admitted to the two participating hospitals.

Exclusion Criteria:

- Catheter-associated infections attributed to hemodialysis catheters.

- Neonates and children.

- Known silver allergy or hypersensitivity.

Study Design

Observational Model: Case-Crossover, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States Emory University Hospital Atlanta Georgia
United States Emory University Hospital Midtown Atlanta Georgia

Sponsors (3)

Lead Sponsor Collaborator
Emory University Baxter Healthcare Corporation, Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary central-line associated bloodstream infections rate per 1,000 central line-days 1 year No
Secondary intravenous catheter related bloodstream infection rate per 1,000 patient-days 1 year No
Secondary colony counts per device analyzed (biofilm analysis) devices due to be changed at day 7 No
Secondary false positive blood culture rate 1 year No
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