Catheter-related Bloodstream InfectionCARBNCT01603914
Central Venous Catheter Replacement Strategies in Adult Patients With Major Burn Injury
A study testing central venous catheter replacement (Arrowgard Blue plus Quad-Lumen CVC ) in people with Catheter-related Bloodstream Infection and Complication of Catheter, run by Hospital Universitario Getafe at 3 sites in Spain.
Trial summary
The aim of this project is to answer the following questions: To determine the incidence of catheter related bacteremia (CRB) with three strategies of central venous catheter exchange in critically ill adult patients with major burn and to determine the regimen that will minimize the risk of bacteremia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheter-related Bloodstream Infection, Complication of Catheter
- What is being tested?
- central venous catheter replacement (Arrowgard Blue plus Quad-Lumen CVC )
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,120 participants
- Where
- 3 sitesSpain
- Study dates
- May 2012to Dec 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (> 18 years old) admitted in a Critical Care Burn Center with a total body surface area (TBSA) greater than 20% and/or smoke inhalation injury.
Who cannot join
- Adults admitted in a Critical Care Burn Center with a Do-Not-Resuscitate (DNAR) order due to severity of injuries.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites, 1 recruiting
- Active, not recruiting
Complejo Hospitalario Universitario de A Coruna
A Coruña, A Coruna
- Active, not recruiting
Hospital de Cruces
Barakaldo, Vizcaya
- Recruiting
Critical Care and Burn Unit, Hospital Universitario de Getafe
Getafe, Madrid, 28905
Oscar Penuelas, MD, 0034-916834982, openuelas@gmail.com
Miguel A De la Cal, MD, 0034-916834982, mcal@ucigetafe.com
About this study
Official title: Comparison of Three Strategies for Changing of Central Venous Catheters in Patients With Serious Burns for the Prevention of Catheter-associated Bacteremia: Randomized Clinical Trial
The aim of this project is to answer the following questions:
To determine the incidence of catheter related bacteremia (CRB) with three strategies of central venous catheter exchange in critically ill adult patients with major burn and to determine the regimen that will minimize the risk of bacteremia.
Read more
To determine the incidence rate of catheter colonization in adult patients with major burns.
The scientific knowledge to be acquired through this project is of likely benefit to the care of critically ill patients with burns injury as follows:
The intention is to improve the outcomes in critically ill patients 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.
Read the detailed description
Aim: To determine the incidence of catheter-related bacteremia (CRB) with three primary schedules of central venous catheter exchange in adult critically ill patients with major burn injury.
Hypothesis: A strategy of catheter exchange according with clinical criteria will result in no more CRB compared with a routine catheter changes without guidewire exchange strategy or frequent guidewire exchange or frequent new-site replacement.
Background: The intravenous catheter-related bacteremia (ICRB) is a nosocomial infection affecting patients admitted to intensive care and that leads to increased morbidity. Accumulative incidence rates of ICRB are 5.5 infections per 1000 catheters-day. Several strategies have been proposed to decrease of the rate of ICRB in critically ill patients. However, there is not agreement to recommend a replacement pattern of central venous catheters in adult critically ill patients with major burns as a strategy for the reduction in intravenous catheter-associated bacteremia.
Objectives. To compare three strategies of replacement from central venous catheters for the prevention of ICRB. Find out the risk of mechanical complications associated with each strategy of central venous catheter replacement.
Method. Randomized, multicenter clinical trial, single blind to compare three strategies for intravenous catheter replacement in patients with major burns: a scheduled wire-guided strategy every six days: second, a scheduled strategy of replacement every six days in a different punction and third, a re-change strategy guided by clinical criteria for suspicion of catheter-associated infection. Primary outcome: catheter colonization rate and rate of intravenous catheter-associated bacteremia. Secondarily, we calculate the incidence rate of colonization of central venous catheter and finally we will analyze the associated complications.
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.
- Being tested
- central venous catheter replacement (Arrowgard Blue plus Quad-Lumen CVC )
- Keywords
- burns, catheter related bacteremia,, infection, central venous catheter,, catheter-related bloodstream, adult critically ill patients
- Medical subject headings
- Burns, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
central venous catheter replacement (Arrowgard Blue plus Quad-Lumen CVC )Device
Also called Catheter Related Bacteremia in Burns, CARBB study
Routine practices for the type of catheter of each participating Unit will be respected. Multilumen central venous catheter will be used (i.e Arrowgard Blue plus Quad-Lumen CVC set). Impregnated Catheter with antiseptics or with antibiotics will be allowed.The anatomical locations selected for the replacement of central venous catheter are: subclavian vein, internal jugular vein, femoral vein and the change will be addressed according to the randomization.
The dressing and maintenance of the catheter will be guided according with the Guides of The Centers for Disease Control and Prevention (CDCs) and a check-in lists will be fill in for each catheter.
A pre-defined stratified analysis will be performed according with: type of catheter, participating unit, and insertion site.
| Study group | Role | What they receive |
|---|---|---|
| scheduled wire-guided every six days | Experimental | scheduled wire-guided every six days and a replacement of the catheter in a different place after 12 days from randomization. Receives: Device: central venous catheter replacement (Arrowgard Blue plus Quad-Lumen CVC ) |
| Scheduled replacement every six days | Experimental | Scheduled replacement every six days in a different location Receives: Device: central venous catheter replacement (Arrowgard Blue plus Quad-Lumen CVC ) |
| replacement guided by clinical criteria | Experimental | re change of catheter strategy guided by clinical suspicious of catheter-related bacteremia and replacement of the catheter in a different location. Receives: Device: central venous catheter replacement (Arrowgard Blue plus Quad-Lumen CVC ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accumulative Incidence rate of catheter-related bacteremia
Measured: participants will be followed for the duration of Burn Center stay, an expected lenght of stay average of 6 weeks (that represents the mean length of stay average in our BUrn Center in 2011)
Secondary outcomes (2)
Accumulative incidence rate of catheter colonization
From date of randomization until the date of first documented progression or date of adverse event (pneumothorax, hemothorax)or death from any cause, whichever came first, assessed up to 18 months.
Measured: participants will be followed for the duration of Burn Center stay, an expected lenght of stay average of 6 weeks (that represents the mean length of stay average in our BUrn Center in 2011)
Mechanical complications of catheter insertion
Neumothorax, hemothorax, arterial puncture,
Measured: during the procedure of central catheter insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2012 (estimated)
- Study startMay 2012
- Primary completionJun 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Catheter-related Bloodstream InfectionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Getafe
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oscar Penuelas, MD, Hospital Universitario Getafe
- Investigators
- Oscar Penuelas, MD, Principal investigator, Critical Care Department and Burn Center. Hospital Universitario de Getafe, Madrid, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01603914
- Sponsor's protocol ID
- PI11/01121
- Other IDs
- ISCIII
- Acronym
- CARB
- Status last verified
- May 2012
- First submitted
- 13 May 2012
- Last updated
- 29 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Silver GM, Klein MB, Herndon DN, Gamelli RL, Gibran NS, Altstein L, McDonald-Smith GP, Tompkins RG, Hunt JL; Inflammation and the Host Response to Trauma, Collaborative Research Program. Standard operating procedures for the clinical management of patients enrolled in a prospective study of Inflammation and the Host Response to Thermal Injury. J Burn Care Res. 2007 Mar-Apr;28(2):222-30. doi: 10.1097/BCR.0B013E318031AA44.
PubMed 17351437O'Mara MS, Reed NL, Palmieri TL, Greenhalgh DG. Central venous catheter infections in burn patients with scheduled catheter exchange and replacement. J Surg Res. 2007 Oct;142(2):341-50. doi: 10.1016/j.jss.2007.03.063. Epub 2007 Jul 12.
PubMed 17631903Brun-Buisson C, Doyon F, Sollet JP, Cochard JF, Cohen Y, Nitenberg G. Prevention of intravascular catheter-related infection with newer chlorhexidine-silver sulfadiazine-coated catheters: a randomized controlled trial. Intensive Care Med. 2004 May;30(5):837-43. doi: 10.1007/s00134-004-2221-9. Epub 2004 Apr 2.
PubMed 15060765
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Three Strategies for Changing of Central Venous Catheters in Patients With Serious Burns for the Prevention of Catheter-associated Bacteremia: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01603914
- Acronym / sponsor ID
- CARB / PI11/01121
- Keywords
- burns, catheter related bacteremia,, infection, central venous catheter,, catheter-related bloodstream, adult critically ill patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,120 participants (estimated)
- Lead sponsor
- Hospital Universitario GetafeUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 23 May 2012 (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.
The aim of this project is to answer the following questions:
To determine the incidence of catheter related bacteremia (CRB) with three strategies of central venous catheter exchange in critically ill adult patients with major burn and to determine the regimen that will minimize the risk of bacteremia.
To determine the incidence rate of catheter colonization in adult patients with major burns.
The scientific knowledge to be acquired through this project is of likely benefit to the care of critically ill patients with burns injury as follows:
The intention is to improve the outcomes in critically ill patients 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.
Detailed description
Aim: To determine the incidence of catheter-related bacteremia (CRB) with three primary schedules of central venous catheter exchange in adult critically ill patients with major burn injury.
Hypothesis: A strategy of catheter exchange according with clinical criteria will result in no more CRB compared with a routine catheter changes without guidewire exchange strategy or frequent guidewire exchange or frequent new-site replacement.
Background: The intravenous catheter-related bacteremia (ICRB) is a nosocomial infection affecting patients admitted to intensive care and that leads to increased morbidity. Accumulative incidence rates of ICRB are 5.5 infections per 1000 catheters-day. Several strategies have been proposed to decrease of the rate of ICRB in critically ill patients. However, there is not agreement to recommend a replacement pattern of central venous catheters in adult critically ill patients with major burns as a strategy for the reduction in intravenous catheter-associated bacteremia.
Objectives. To compare three strategies of replacement from central venous catheters for the prevention of ICRB. Find out the risk of mechanical complications associated with each strategy of central venous catheter replacement.
Method. Randomized, multicenter clinical trial, single blind to compare three strategies for intravenous catheter replacement in patients with major burns: a scheduled wire-guided strategy every six days: second, a scheduled strategy of replacement every six days in a different punction and third, a re-change strategy guided by clinical criteria for suspicion of catheter-associated infection. Primary outcome: catheter colonization rate and rate of intravenous catheter-associated bacteremia. Secondarily, we calculate the incidence rate of colonization of central venous catheter and finally we will analyze the associated complications.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| scheduled wire-guided every six days | Experimental | Device: central venous catheter replacement (Arrowgard Blue plus Quad-Lumen CVC )scheduled wire-guided every six days and a replacement of the catheter in a different place after 12 days from randomization. |
| Scheduled replacement every six days | Experimental | Device: central venous catheter replacement (Arrowgard Blue plus Quad-Lumen CVC )Scheduled replacement every six days in a different location |
| replacement guided by clinical criteria | Experimental | Device: central venous catheter replacement (Arrowgard Blue plus Quad-Lumen CVC )re change of catheter strategy guided by clinical suspicious of catheter-related bacteremia and replacement of the catheter in a different location. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults (> 18 years old) admitted in a Critical Care Burn Center with a total body surface area (TBSA) greater than 20% and/or smoke inhalation injury.
Key exclusion criteria (1 listed)
- Adults admitted in a Critical Care Burn Center with a Do-Not-Resuscitate (DNAR) order due to severity of injuries.
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 |
|---|---|---|
| central venous catheter replacement (Arrowgard Blue plus Quad-Lumen CVC )Also: Catheter Related Bacteremia in Burns, CARBB studyRoutine practices for the type of catheter of each participating Unit will be respected. Multilumen central venous catheter will be used (i.e Arrowgard Blue plus Quad-Lumen CVC set). Impregnated Catheter with antiseptics or with antibiotics will be allowed.The anatomical locations selected for the replacement of central venous catheter are: subclavian vein, internal jugular vein, femoral vein and the change will be addressed according to the randomization. The dressing and maintenance of the catheter will be guided according with the Guides of The Centers for Disease Control and Prevention (CDCs) and a check-in lists will be fill in for each catheter. A pre-defined stratified analysis will be performed according with: type of catheter, participating unit, and insertion site. | Device | Scheduled replacement every six days, replacement guided by clinical criteria, scheduled wire-guided every six days |
Primary outcome
Accumulative Incidence rate of catheter-related bacteremia
Time frame: participants will be followed for the duration of Burn Center stay, an expected lenght of stay average of 6 weeks (that represents the mean length of stay average in our BUrn Center in 2011)
2 secondary outcomes
Accumulative incidence rate of catheter colonization
Time frame: participants will be followed for the duration of Burn Center stay, an expected lenght of stay average of 6 weeks (that represents the mean length of stay average in our BUrn Center in 2011)
Mechanical complications of catheter insertion
Time frame: during the procedure of central catheter insertion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2012.
- Background: PubMed 17351437Silver GM, Klein MB, Herndon DN, Gamelli RL, Gibran NS, Altstein L, McDonald-Smith GP, Tompkins RG, Hunt JL; Inflammation and the Host Response to Trauma, Collaborative Research Program. Standard operating procedures for the clinical management of patients enrolled in a prospective study of Inflammation and the Host Response to Thermal Injury. J Burn Care Res. 2007 Mar-Apr;28(2):222-30. doi: 10.1097/BCR.0B013E318031AA44.
- Results publication: PubMed 17631903O'Mara MS, Reed NL, Palmieri TL, Greenhalgh DG. Central venous catheter infections in burn patients with scheduled catheter exchange and replacement. J Surg Res. 2007 Oct;142(2):341-50. doi: 10.1016/j.jss.2007.03.063. Epub 2007 Jul 12.
- Results publication: PubMed 15060765Brun-Buisson C, Doyon F, Sollet JP, Cochard JF, Cohen Y, Nitenberg G. Prevention of intravascular catheter-related infection with newer chlorhexidine-silver sulfadiazine-coated catheters: a randomized controlled trial. Intensive Care Med. 2004 May;30(5):837-43. doi: 10.1007/s00134-004-2221-9. Epub 2004 Apr 2.
- The American Burn Association is dedicated to improving the lives of everyone affected by burn injury through patient care, education, research and advocacy.Link provided by the sponsor.
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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.
Oscar Penuelas, MD principal investigator
Critical Care Department and Burn Center. Hospital Universitario de Getafe, Madrid, Spain
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing central venous catheter replacement (Arrowgard Blue plus Quad-Lumen CVC ) in people with Catheter-related Bloodstream Infection and Complication of Catheter, run by Hospital Universitario Getafe at 3 sites in Spain.
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 29 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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?
Contact Oscar Penuelas, MD (0034-916834982, openuelas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accumulative Incidence rate of catheter-related bacteremia (time frame: participants will be followed for the duration of Burn Center stay, an expected lenght of stay average of 6 weeks (that represents the mean length of stay average in our BUrn Center in 2011)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01603914, which also lists 3 linked publications.
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 29 Aug 2012.