BurnsNCT00583882
Central Venous Catheter Replacement Strategies in Patients With Acute Burn Injury
A study testing Routine change of central venous catheters in people with Burns, run by Shriners Hospitals for Children at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Burns
- What is being tested?
- Routine change of central venous catheters
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Jul 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Burn patient with central venous catheter
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Shriners Hospital for Children Northern California
Sacramento, California, 95817
Michael S O'Mara, MD, 916-452-2050, momara@shrinenet.org
About this study
Official title: A Prospective, Randomized Study to Evaluate the Risks Related to Central Venous Catheter Replacement Strategies in Patients With Acute Burn Injury
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.
Read more
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
Read the 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.
- Conditions
- Burns
- Being tested
- Routine change of central venous catheters
- Keywords
- Central Venous Catheter, Guidewire, Burn
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine change of central venous cathetersOther
Changeing CVCs on a regular basis to decrease infection rate.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Change every 6 days, rewire every 6 days Receives: Other: Routine change of central venous catheters |
| 2 | Other | New site every 6 days Receives: Other: Routine change of central venous catheters |
| 3 | Other | New site every 12 days Receives: Other: Routine change of central venous catheters |
What is being measured
The primary outcome is the main question the study is designed to answer.
CVC related blood stream infections.
Measured: patient discharge/CVC removal
Secondary outcomes (1)
CVC mechanical complications
Measured: patient discharge/CVC removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2008 (estimated)
- Study startJul 2006
- Primary completionJul 2009 (estimated)
- Study completionJul 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shriners Hospitals for Children
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00583882
- Sponsor's protocol ID
- 200614292-1
- Status last verified
- Dec 2007
- First submitted
- 26 Dec 2007
- Last updated
- 2 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Study to Evaluate the Risks Related to Central Venous Catheter Replacement Strategies in Patients With Acute Burn Injury
- ClinicalTrials.gov ID
- NCT00583882
- Acronym / sponsor ID
- 200614292-1
- Conditions
- Burns
- Keywords
- Central Venous Catheter, Guidewire, Burn
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shriners Hospitals for ChildrenUniversity, hospital or other
- Collaborators
- University of California, Davis
- Study start
- Jul 2006
- Primary completion
- Jul 2009 (estimated)
- Study completion
- Jul 2009 (estimated)
- First posted
- 2 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: Routine change of central venous cathetersChange every 6 days, rewire every 6 days |
| 2 | Other | Other: Routine change of central venous cathetersNew site every 6 days |
| 3 | Other | Other: Routine change of central venous cathetersNew site every 12 days |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Burn patient with central venous catheter
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine change of central venous cathetersChangeing CVCs on a regular basis to decrease infection rate. | Other | 1, 2, 3 |
Primary outcome
CVC related blood stream infections.
Time frame: patient discharge/CVC removal
1 secondary outcome
CVC mechanical complications
Time frame: patient discharge/CVC removal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2008.
Related trials for Burns
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Sepsis, Sepsis-induced Coagulopathy
Not yet recruitingObservational study
Hypertrophic Scar Prosthetic Pressure in Burn Amputee
Amputation Stump, Burn Injury
Not yet recruiting
Effect of Short-Video Distraction During Burn Dressing on Anxiety, Pain, and Fear in Children
Burn Injury, Procedural Anxiety
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Peer Bullying Intervention, Vodcast
RecruitingPhase 2
Dupixent in Adults With Refractory Post-Burn Pruritus in an Ambulatory Clinic
Pruritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shriners Hospital for Children Northern California
Sacramento, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine change of central venous catheters in people with Burns, run by Shriners Hospitals for Children at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CVC related blood stream infections. (time frame: patient discharge/CVC removal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2008.