Central Venous Catheter Replacement Strategies in Patients With Acute Burn Injury

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by Shriners Hospitals for Children.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of California, Davis
Information provided by:
Shriners Hospitals for Children
ClinicalTrials.gov Identifier:
NCT00583882
First received: December 26, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
  Purpose

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


Condition Intervention
Burns
Other: Routine change of central venous catheters

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Prospective, Randomized Study to Evaluate the Risks Related to Central Venous Catheter Replacement Strategies in Patients With Acute Burn Injury

Resource links provided by NLM:


Further study details as provided by Shriners Hospitals for Children:

Primary Outcome Measures:
  • CVC related blood stream infections. [ Time Frame: patient discharge/CVC removal ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • CVC mechanical complications [ Time Frame: patient discharge/CVC removal ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: July 2006
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Change every 6 days, rewire every 6 days
Other: Routine change of central venous catheters
Changeing CVCs on a regular basis to decrease infection rate.
2
New site every 6 days
Other: Routine change of central venous catheters
Changeing CVCs on a regular basis to decrease infection rate.
3
New site every 12 days
Other: Routine change of central venous catheters
Changeing CVCs on a regular basis to decrease infection rate.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Burn patient with central venous catheter

Exclusion Criteria:

  • none
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00583882

Locations
United States, California
Shriners Hospital for Children Northern California Recruiting
Sacramento, California, United States, 95817
Contact: Michael S O'Mara, MD    916-452-2050    momara@shrinenet.org   
Sponsors and Collaborators
Shriners Hospitals for Children
University of California, Davis
  More Information

No publications provided

Responsible Party: Michael S. O'Mara, Shriners Hosptial for Children Northern California
ClinicalTrials.gov Identifier: NCT00583882     History of Changes
Other Study ID Numbers: 200614292-1
Study First Received: December 26, 2007
Last Updated: December 26, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Shriners Hospitals for Children:
Central Venous Catheter
Guidewire
Burn

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014