Central Venous Catheter Replacement Strategies in Patients With Acute Burn Injury
Primary Purpose
Burns
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Routine change of central venous catheters
Sponsored by

About this trial
This is an interventional prevention trial for Burns focused on measuring Central Venous Catheter, Guidewire, Burn
Eligibility Criteria
Inclusion Criteria:
- Burn patient with central venous catheter
Exclusion Criteria:
- none
Sites / Locations
- Shriners Hospital for Children Northern CaliforniaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
1
2
3
Arm Description
Change every 6 days, rewire every 6 days
New site every 6 days
New site every 12 days
Outcomes
Primary Outcome Measures
CVC related blood stream infections.
Secondary Outcome Measures
CVC mechanical complications
Full Information
NCT ID
NCT00583882
First Posted
December 26, 2007
Last Updated
December 26, 2007
Sponsor
Shriners Hospitals for Children
Collaborators
University of California, Davis
1. Study Identification
Unique Protocol Identification Number
NCT00583882
Brief Title
Central Venous Catheter Replacement Strategies in Patients With Acute Burn Injury
Official Title
A Prospective, Randomized Study to Evaluate the Risks Related to Central Venous Catheter Replacement Strategies in Patients With Acute Burn Injury
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Unknown status
Study Start Date
July 2006 (undefined)
Primary Completion Date
July 2009 (Anticipated)
Study Completion Date
July 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Shriners Hospitals for Children
Collaborators
University of California, Davis
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This project proposes to answer the following questions:
To determine the incidence of infection with three primary schedules of central venous catheter exchange in pediatric burn patients and to determine the regimen that will minimize infectious risk in children with burns.
The scientific knowledge to be acquired through this project is of likely benefit to the care of children with orthopaedic problems, spinal cord injuries or burns as follows:
The intention is to improve the outcomes in burned children by minimizing one of the most frequent causes of infection in the burn intensive care unit, those from central venous catheters. Decreasing infections will decrease morbidity, decrease length of stay, decrease costs, and decrease mortality in burned children
Detailed Description
Aim: To determine the incidence of infection with three primary schedules of central venous catheter exchange in pediatric burn patients and to create a system that will minimize infectious risk in this patient population.
Hypothesis: A strategy of routine catheter changes without guidewire exchange will result in no more infections and a decreased risk of mechanical complications over frequent guidewire exchange or frequent new-site replacement.
Background: Reviews of burned children have implied that it is safe to change CVCs on a weekly basis, either by new site insertion or by wire exchange. In non-burn populations the routine use of wire exchange may increase infectious risk. Laboratory investigations have shown that the longer catheters are in place, the more often they are colonized with bacteria; this translates to an increase in catheter infection and patient sepsis. Centers for Disease Control recommendations note that catheters should not be routinely changed. The burn literature has disagreed with this concept, proffering that the change in microbial milieu from the burn wound increases infection risk, and national data indicates that burn units have three to four times higher rates of catheter related bloodstream infections than do other intensive care units. There is a trend in the existent retrospective data that using wires to change central venous catheters increases the risk of infection: CVCs changed to a new site have an infection rate of 16.6 per 1000 catheter days, whereas those changed by means of a wire have a rate of 25.2 per 1000 catheter days.
Methods: Patients will be randomized to three intervention groups: a frequent (6 days) moving of catheters to new sites; an alternating schedule of wire exchanges and new sites (every 6 and 12 days); and a less frequent moving of catheters to new sites (12 days) without wire exchange. This project requires enough patients to show a difference between three intervention groups. A significant decrease in infection rate would be from the current 20 infections per 1000 catheter days to approximately 15 per 1000 catheter days. This would require a minimum of 1000 catheter days per group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns
Keywords
Central Venous Catheter, Guidewire, Burn
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
Change every 6 days, rewire every 6 days
Arm Title
2
Arm Type
Other
Arm Description
New site every 6 days
Arm Title
3
Arm Type
Other
Arm Description
New site every 12 days
Intervention Type
Other
Intervention Name(s)
Routine change of central venous catheters
Intervention Description
Changeing CVCs on a regular basis to decrease infection rate.
Primary Outcome Measure Information:
Title
CVC related blood stream infections.
Time Frame
patient discharge/CVC removal
Secondary Outcome Measure Information:
Title
CVC mechanical complications
Time Frame
patient discharge/CVC removal
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Burn patient with central venous catheter
Exclusion Criteria:
none
Facility Information:
Facility Name
Shriners Hospital for Children Northern California
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael S O'Mara, MD
Phone
916-452-2050
Email
momara@shrinenet.org
12. IPD Sharing Statement
Learn more about this trial
Central Venous Catheter Replacement Strategies in Patients With Acute Burn Injury
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