NCT00878683

Brief 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. 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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2009

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

May 5, 2015

Status Verified

May 1, 2015

Enrollment Period

1.8 years

First QC Date

April 7, 2009

Last Update Submit

May 1, 2015

Conditions

Intensive Care

Outcome Measures

Primary Outcomes (1)

  • Catheter site inspection

    Baseline, Daily

Study Arms (2)

1

EXPERIMENTAL

Device and standard catheter

Device: silicone catheter boot

2

NO INTERVENTION

Standard catheter

Interventions

silicone catheter bootDEVICE

silicone device using Dermabond

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Stephen Waller, MD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 7, 2009

First Posted

April 9, 2009

Study Start

July 1, 2009

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

May 5, 2015

Record last verified: 2015-05