Comparison of an Antibiotic Impregnated PICC Catheter Versus a Regular PICC Catheter in a Tertiary Care Setting

Peripherally Inserted Central Catheters Clinical Trial

Official title:

Randomized Double Blind Comparison of an Antibiotic Impregnated PICC Catheter Versus a Regular PICC Catheter in a Tertiary Care Setting

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01765738
• Other study ID #: PICC Line Comparison
• Status: Withdrawn
• Phase: Phase 2
• Start date: February 2013
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine whether antibiotic impregnated PICC catheters have a lower infection rate than a conventional PICC catheter in a tertiary care patient population. Secondary goals will be to determine if there is a difference between the two catheters with early and late infections, to determine the cost comparison including extra cost of treatment for a line related infection, to determine if there are any non-infectious related complication differences between the two catheters.

Description:

All patients who are referred to VIR for a PICC line will be evaluated to see if they satisfy the inclusion/exclusion criteria. The study will be discussed with those who do and informed consent will be obtained from those wishing to participate. The patient will then be randomized to one of two types of PICC lines. All lines will be placed by identical technique. This will include sterile technique, placement via a vein of the upper arm using ultrasound guidance, and positioning of the catheter tip under fluoroscopic guidance. A database of all catheters placed will be kept. Records will be reviewed at 1 week, 30 days, and 60 days by the Interventional Radiology Fellow.Review will include length of time catheter was in place, whether treatment was completed, whether catheter was removed prematurely, the clinical reason for removal, results of other imaging tests, and results of cultures on any catheters removed for suspicion of infection. Any non-infectious complications related to the catheter will also be noted. The reviewer will be blinded to which catheter was used during the procedure.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Greater than or equal to 18 years of age

• Have been scheduled for a medically necessary PICC placement

Exclusion Criteria:

• Less than 18 years of age

Related Conditions & MeSH terms

• Peripherally Inserted Central Catheters

Intervention

Device:
• PICC (Cook, Bard)
Comparison of antibiotic coated PICC vs. non-coated PICC

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infection rate	Records will be reviewed up to 60 days post PICC line procedure to assess whether catheter was removed prematurely for infection and results of cultures on any catheters removed.	60 days