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Comparison of Infection Rates Among Patients Using Two Catheter Access Devices

NCT ID: NCT00965198

Last Updated: 2013-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Catheter-Related Infections Bacteremia

Keywords

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Catheters, Indwelling Biofilms

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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Clearlink Arm, EUH

Standard catheter access device at Emory University Hospital

No interventions assigned to this group

VLINK Arm, EUHM

Novel, silver-coated catheter access device at Emory University Hospital Midtown

No interventions assigned to this group

Clearlink, EUM

Standard catheter access device at at Emory University Hospital Midtown

No interventions assigned to this group

VLINK Arm, EUH

Novel, silver-coated catheter access device at Emory University Hospital

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role lead

Responsible Party

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Jesse Thomas Jacob

Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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James P Steinberg, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Jesse T Jacob, MD

Role: STUDY_DIRECTOR

Emory University

Sheri Chernetsky Tejedor, MD

Role: STUDY_DIRECTOR

Emory University

Locations

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Emory University Hospital

Atlanta, Georgia, United States

Site Status

Emory University Hospital Midtown

Atlanta, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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B16682

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00016682

Identifier Type: -

Identifier Source: org_study_id