Comparison of Infection Rates Among Patients Using Two Catheter Access Devices

This study has been completed.
Sponsor:
Collaborators:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Jesse Thomas Jacob, Emory University
ClinicalTrials.gov Identifier:
NCT00965198
First received: July 16, 2009
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

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
Catheter-Related Infections
Bacteremia

Study Type: Observational
Study Design: 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

Further study details as provided by Emory University:

Primary Outcome Measures:
  • central-line associated bloodstream infections rate per 1,000 central line-days [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • intravenous catheter related bloodstream infection rate per 1,000 patient-days [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • colony counts per device analyzed (biofilm analysis) [ Time Frame: devices due to be changed at day 7 ] [ Designated as safety issue: No ]
  • false positive blood culture rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Samples for biofilm analysis may be banked for further study.


Enrollment: 10000
Study Start Date: November 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00965198

Locations
United States, Georgia
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Emory University Hospital
Atlanta, Georgia, United States, 30033
Sponsors and Collaborators
Emory University
Baxter Healthcare Corporation
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
  More Information

No publications provided

Responsible Party: Jesse Thomas Jacob, Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00965198     History of Changes
Other Study ID Numbers: IRB00016682, B16682
Study First Received: July 16, 2009
Last Updated: November 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Catheters, Indwelling
Biofilms

Additional relevant MeSH terms:
Infection
Communicable Diseases
Bacteremia
Catheter-Related Infections
Bacterial Infections
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014