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Central Venous Catheter Replacement Strategies in Adult Patients With Major Burn Injury (CARB)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2012 by Hospital Universitario Getafe
Sponsor:
Information provided by (Responsible Party):
Oscar Penuelas, MD, Hospital Universitario Getafe
ClinicalTrials.gov Identifier:
NCT01603914
First received: May 13, 2012
Last updated: August 28, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Catheter-related Bloodstream Infection
Complication of Catheter
Device: central venous catheter replacement (Arrowgard Blue plus Quad-Lumen CVC )

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hospital Universitario Getafe:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]
    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.

  • Mechanical complications of catheter insertion [ Time Frame: during the procedure of central catheter insertion ] [ Designated as safety issue: No ]
    Neumothorax, hemothorax, arterial puncture,


Estimated Enrollment: 1120
Study Start Date: May 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: scheduled wire-guided every six days
scheduled wire-guided every six days and a replacement of the catheter in a different place after 12 days from randomization.
Device: central venous catheter replacement (Arrowgard Blue plus Quad-Lumen CVC )

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.

Other Name: Catheter Related Bacteremia in Burns, CARBB study
Experimental: Scheduled replacement every six days
Scheduled replacement every six days in a different location
Device: central venous catheter replacement (Arrowgard Blue plus Quad-Lumen CVC )

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.

Other Name: Catheter Related Bacteremia in Burns, CARBB study
Experimental: replacement guided by clinical criteria
re change of catheter strategy guided by clinical suspicious of catheter-related bacteremia and replacement of the catheter in a different location.
Device: central venous catheter replacement (Arrowgard Blue plus Quad-Lumen CVC )

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.

Other Name: Catheter Related Bacteremia in Burns, CARBB study

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Adults admitted in a Critical Care Burn Center with a Do-Not-Resuscitate (DNAR) order due to severity of injuries.
  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: NCT01603914

Contacts
Contact: Oscar Penuelas, MD 0034-916834982 openuelas@gmail.com
Contact: Miguel A De la Cal, MD 0034-916834982 mcal@ucigetafe.com

Locations
Spain
Critical Care and Burn Unit, Hospital Universitario de Getafe Recruiting
Getafe, Madrid, Spain, 28905
Contact: Oscar Penuelas, MD    0034-916834982    openuelas@gmail.com   
Contact: Miguel A De la Cal, MD    0034-916834982    mcal@ucigetafe.com   
Sub-Investigator: Inmaculada Alia, MD         
Sub-Investigator: Karen Gomez Mediavilla, MD         
Sub-Investigator: Marcos Varela         
Hospital de Cruces Active, not recruiting
Barakaldo, Vizcaya, Spain
Complejo Hospitalario Universitario de A Coruna Active, not recruiting
A Coruna, Spain
Sponsors and Collaborators
Hospital Universitario Getafe
Investigators
Principal Investigator: Oscar Penuelas, MD Critical Care Department and Burn Center. Hospital Universitario de Getafe, Madrid, Spain
  More Information

Additional Information:
Publications:
Responsible Party: Oscar Penuelas, MD, MD, Attending of Critica Care Department and Burns Center, Hospital Universitario de Getafe, Hospital Universitario Getafe
ClinicalTrials.gov Identifier: NCT01603914     History of Changes
Other Study ID Numbers: PI11/01121, ISCIII
Study First Received: May 13, 2012
Last Updated: August 28, 2012
Health Authority: Spain: Comité Ético de Investigación Clínica
Spain: Ministry of Health

Keywords provided by Hospital Universitario Getafe:
burns, catheter related bacteremia,
infection, central venous catheter,
catheter-related bloodstream, adult critically ill patients

Additional relevant MeSH terms:
Infection

ClinicalTrials.gov processed this record on November 25, 2014