Comparison of Infection Rates Among Patients Using Two Catheter Access Devices

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00965198
Recruitment Status : Completed
First Posted : August 25, 2009
Last Update Posted : November 21, 2013
Centers for Disease Control and Prevention
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Jesse Thomas Jacob, Emory University

Brief 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.

Condition or disease
Catheter-Related Infections Bacteremia

Study Type : Observational
Actual Enrollment : 10000 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Comparison of a Novel Silver-Coated Catheter Access Device and a Standard Catheter Access Device: A Dual Center Cross-Over Study
Study Start Date : November 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

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

Primary Outcome Measures :
  1. central-line associated bloodstream infections rate per 1,000 central line-days [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. intravenous catheter related bloodstream infection rate per 1,000 patient-days [ Time Frame: 1 year ]
  2. colony counts per device analyzed (biofilm analysis) [ Time Frame: devices due to be changed at day 7 ]
  3. false positive blood culture rate [ Time Frame: 1 year ]

Biospecimen Retention:   Samples Without DNA
Samples for biofilm analysis may be banked for further study.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Nearly all hospitalized patients require some form of indwelling IV catheter as part of routine care, and approximately 20% of patient-days include central lines. All adult patients admitted to 2 Emory affiliated hospitals (Emory University Hospital and Emory University Hospital Midtown) during the study period will be included in the study population.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00965198

United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30033
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Sponsors and Collaborators
Emory University
Centers for Disease Control and Prevention
Baxter Healthcare Corporation
Principal Investigator: James P Steinberg, MD Emory University
Study Director: Jesse T Jacob, MD Emory University
Study Director: Sheri Chernetsky Tejedor, MD Emory University

Responsible Party: Jesse Thomas Jacob, Investigator, Emory University Identifier: NCT00965198     History of Changes
Other Study ID Numbers: IRB00016682
B16682 ( Other Identifier: Other )
First Posted: August 25, 2009    Key Record Dates
Last Update Posted: November 21, 2013
Last Verified: November 2013

Keywords provided by Jesse Thomas Jacob, Emory University:
Catheters, Indwelling

Additional relevant MeSH terms:
Catheter-Related Infections
Bacterial Infections
Systemic Inflammatory Response Syndrome
Pathologic Processes