NCT00583882

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 26, 2007

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 2, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

January 2, 2008

Status Verified

December 1, 2007

Enrollment Period

3 years

First QC Date

December 26, 2007

Last Update Submit

December 26, 2007

Conditions

Burns

Keywords

Central Venous CatheterGuidewireBurn

Outcome Measures

Primary Outcomes (1)

  • CVC related blood stream infections.

    patient discharge/CVC removal

Secondary Outcomes (1)

  • CVC mechanical complications

    patient discharge/CVC removal

Study Arms (3)

1

OTHER

Change every 6 days, rewire every 6 days

Other: Routine change of central venous catheters

2

OTHER

New site every 6 days

Other: Routine change of central venous catheters

3

OTHER

New site every 12 days

Other: Routine change of central venous catheters

Interventions

Routine change of central venous cathetersOTHER

Changeing CVCs on a regular basis to decrease infection rate.

123

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Burn patient with central venous catheter

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shriners Hospital for Children Northern California

Sacramento, California, 95817, United States

RECRUITING

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

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

Study Record Dates

First Submitted

December 26, 2007

First Posted

January 2, 2008

Study Start

July 1, 2006

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

January 2, 2008

Record last verified: 2007-12

Locations

US(1)