Comparison of Infection Rates Among Patients Using Two Catheter Access Devices

Comparison of a Novel Silver-Coated Catheter Access Device and a Standard Catheter Access Device: A Dual Center Cross-Over Study

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.

Study Overview

• Status: Completed
• Conditions: Bacteremia; Catheter-Related Infections

• Study Type: Observational
• Enrollment (Actual): 10000

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Emory University Hospital Midtown
    • Atlanta, Georgia, United States, 30033
      • Emory University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Clearlink Arm, EUH; Standard catheter access device at Emory University Hospital
VLINK Arm, EUHM; Novel, silver-coated catheter access device at Emory University Hospital Midtown
Clearlink, EUM; Standard catheter access device at at Emory University Hospital Midtown
VLINK Arm, EUH; Novel, silver-coated catheter access device at Emory University Hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
central-line associated bloodstream infections rate per 1,000 central line-days	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: Baxter Healthcare Corporation; Centers for Disease Control and Prevention
• Investigators: Principal Investigator: James P Steinberg, MD, Emory University; Study Director: Jesse T Jacob, MD, Emory University; Study Director: Sheri Chernetsky Tejedor, MD, Emory University

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: July 16, 2009
• First Submitted That Met QC Criteria: August 22, 2009
• First Posted (Estimate): August 25, 2009

Study Record Updates

• Last Update Posted (Estimate): November 21, 2013
• Last Update Submitted That Met QC Criteria: November 19, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Catheters, Indwelling; Biofilms
• Additional Relevant MeSH Terms: Pathologic Processes; Systemic Inflammatory Response Syndrome; Inflammation; Bacterial Infections; Bacterial Infections and Mycoses; Sepsis; Infections; Bacteremia; Catheter-Related Infections
• Other Study ID Numbers: IRB00016682; B16682 (Other Identifier: Other)