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Comparison of Infection Rates Among Patients Using Two Catheter Access Devices

Emory University logo

Emory University

Status

Completed

Conditions

Bacteremia
Catheter-Related Infections

Study type

Observational

Funder types

Other
Other U.S. Federal agency
Industry

Identifiers

NCT00965198
IRB00016682
B16682 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

10,000 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

10,000 participants in 4 patient groups

Clearlink Arm, EUH
Description:
Standard catheter access device at Emory University Hospital
VLINK Arm, EUHM
Description:
Novel, silver-coated catheter access device at Emory University Hospital Midtown
Clearlink, EUM
Description:
Standard catheter access device at at Emory University Hospital Midtown
VLINK Arm, EUH
Description:
Novel, silver-coated catheter access device at Emory University Hospital

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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