Catheter-Related InfectionsNCT00965198
Comparison of Infection Rates Among Patients Using Two Catheter Access Devices
An observational study of Catheter-Related Infections and Bacteremia, run by Emory University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheter-Related Infections, Bacteremia
- How many people
- 10,000 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2009to Jul 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- All adult patients admitted to the two participating hospitals.
Who cannot join
- Catheter-associated infections attributed to hemodialysis catheters.
- Neonates and children.
- Known silver allergy or hypersensitivity.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Emory University Hospital
Atlanta, Georgia, 30033
Emory University Hospital Midtown
Atlanta, Georgia, 30308
About this study
Official title: 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.
- Conditions
- Catheter-Related Infections, Bacteremia
- Keywords
- Catheters, Indwelling, Biofilms
- Medical subject headings
- Catheter-Related Infections, Bacteremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
central-line associated bloodstream infections rate per 1,000 central line-days
Measured: 1 year
Secondary outcomes (3)
intravenous catheter related bloodstream infection rate per 1,000 patient-days
Measured: 1 year
colony counts per device analyzed (biofilm analysis)
Measured: devices due to be changed at day 7
false positive blood culture rate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2009 (estimated)
- Study startNov 2009
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter-Related InfectionsStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Baxter Healthcare Corporation
- Responsible party
- Principal investigator, Jesse Thomas Jacob, Emory University
- Investigators
- James P Steinberg, MD, Principal investigator, Emory UniversityJesse T Jacob, MD, Study director, Emory UniversitySheri Chernetsky Tejedor, MD, Study director, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00965198
- Sponsor's protocol ID
- IRB00016682
- Other IDs
- B16682
- Status last verified
- Nov 2013
- First submitted
- 16 Jul 2009
- Last updated
- 21 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a Novel Silver-Coated Catheter Access Device and a Standard Catheter Access Device: A Dual Center Cross-Over Study
- ClinicalTrials.gov ID
- NCT00965198
- Acronym / sponsor ID
- IRB00016682
- Conditions
- Catheter-Related Infections, Bacteremia
- Keywords
- Catheters, Indwelling, Biofilms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,000 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Baxter Healthcare Corporation
- Study start
- Nov 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 25 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All adult patients admitted to the two participating hospitals.
Key exclusion criteria (3 listed)
- Catheter-associated infections attributed to hemodialysis catheters.
- Neonates and children.
- Known silver allergy or hypersensitivity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
central-line associated bloodstream infections rate per 1,000 central line-days
Time frame: 1 year
3 secondary outcomes
intravenous catheter related bloodstream infection rate per 1,000 patient-days
Time frame: 1 year
colony counts per device analyzed (biofilm analysis)
Time frame: devices due to be changed at day 7
false positive blood culture rate
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James P Steinberg, MD principal investigator
Emory University
Jesse T Jacob, MD study director
Emory University
Sheri Chernetsky Tejedor, MD study director
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Catheter-Related Infections and Bacteremia, run by Emory University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
central-line associated bloodstream infections rate per 1,000 central line-days (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2013.