Intensive CareNCT00878683
Novel Device for Reducing Catheter-Related Infections
A study testing silicone catheter boot in people with Intensive Care, run by University of Kansas.
Trial summary
This study is a pilot study of the safety, tolerability and efficacy of an investigational central venous catheter device used in conjunction with a standard central venous catheter. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care
- What is being tested?
- silicone catheter boot
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2009to Apr 2011
- Phase
- Interventional
- 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
Who may be able to join
- Admission in the ICU at time of catheter insertion
- Indication for central venous catheter placement
- De novo catheter insertion in the subclavian or internal jugular veins
Who cannot join
- Anticipated catheter duration < 72 hours
- Planned guidewire exchange
- Documented bacteremia within 48 hours prior to catheter placement
- Extensive skin breakdown near the site of potential catheter placement
- Emergent line placement
- Screening labs with ANC < 500 or platelets < 50K
- Hypersensitivity to cyanoacrylates or formaldehyde
- Prior enrollment in study
About this study
Official title: Exploring the Use of a Novel Device for Reducing Catheter-Related Bloodstream Infections
This study is a pilot study of the safety, tolerability and efficacy of an investigational central venous catheter device used in conjunction with a standard central venous catheter. The hypothesis is that utilization of a catheter device incorporating cyanoacrylate will reduce catheter colonization by bacteria, and may decrease the rate of catheter-related bloodstream infections.
- Conditions
- Intensive Care
- Being tested
- silicone catheter boot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
silicone catheter bootDevice
silicone device using Dermabond
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Device and standard catheter Receives: Device: silicone catheter boot |
| 2 | No intervention | Standard catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Catheter site inspection
Measured: Baseline, Daily
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2009 (estimated)
- Study startJul 2009
- Primary completionApr 2011
- Study completionApr 2011
Why it stopped: Never received IRB approval; Withdrawn before enrollment ever started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive CareStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas
- Sponsor type
- University, hospital or other
- Collaborators
- University of Missouri-Columbia
- Investigators
- Stephen Waller, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00878683
- Sponsor's protocol ID
- 11525
- Status last verified
- May 2015
- First submitted
- 7 Apr 2009
- Last updated
- 5 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Use of a Novel Device for Reducing Catheter-Related Bloodstream Infections
- ClinicalTrials.gov ID
- NCT00878683
- Acronym / sponsor ID
- 11525
- Conditions
- Intensive Care
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Never received IRB approval; Withdrawn before enrollment ever started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of KansasUniversity, hospital or other
- Collaborators
- University of Missouri-Columbia
- Study start
- Jul 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 9 Apr 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.
This study is a pilot study of the safety, tolerability and efficacy of an investigational central venous catheter device used in conjunction with a standard central venous catheter. The hypothesis is that utilization of a catheter device incorporating cyanoacrylate will reduce catheter colonization by bacteria, and may decrease the rate of catheter-related bloodstream infections.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: silicone catheter bootDevice and standard catheter |
| 2 | No intervention | –Standard catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Admission in the ICU at time of catheter insertion
- Indication for central venous catheter placement
- De novo catheter insertion in the subclavian or internal jugular veins
Key exclusion criteria (8 listed)
- Anticipated catheter duration < 72 hours
- Planned guidewire exchange
- Documented bacteremia within 48 hours prior to catheter placement
- Extensive skin breakdown near the site of potential catheter placement
- Emergent line placement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| silicone catheter bootsilicone device using Dermabond | Device | 1 |
Primary outcome
Catheter site inspection
Time frame: Baseline, Daily
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2015.
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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.
Stephen Waller, MD principal investigator
University of Kansas Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing silicone catheter boot in people with Intensive Care, run by University of Kansas.
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 3 inclusion and 8 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: withdrawn, as of the sponsor's last update on 5 May 2015. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Catheter site inspection (time frame: Baseline, Daily). 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 5 May 2015.