NCT01603914

Brief 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. 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.

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
1,120

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2012

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 23, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

August 29, 2012

Status Verified

May 1, 2012

Enrollment Period

2.1 years

First QC Date

May 13, 2012

Last Update Submit

August 28, 2012

Conditions

Catheter-related Bloodstream InfectionComplication of Catheter

Keywords

burns, catheter related bacteremia,infection, central venous catheter,catheter-related bloodstream, adult critically ill patients

Outcome Measures

Primary Outcomes (1)

  • Accumulative Incidence rate of catheter-related bacteremia

    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

    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

    during the procedure of central catheter insertion

Study Arms (3)

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.

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

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.

Device: central venous catheter replacement (Arrowgard Blue plus Quad-Lumen CVC )

Interventions

central venous catheter replacement (Arrowgard Blue plus Quad-Lumen CVC )DEVICE

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.

Also known as: Catheter Related Bacteremia in Burns, CARBB study
Scheduled replacement every six daysreplacement guided by clinical criteriascheduled wire-guided every six days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Complejo Hospitalario Universitario de A Coruna

A Coruña, A Coruna, Spain

ACTIVE NOT RECRUITING

Critical Care and Burn Unit, Hospital Universitario de Getafe

Getafe, Madrid, 28905, Spain

RECRUITING

Hospital de Cruces

Barakaldo, Vizcaya, Spain

ACTIVE NOT RECRUITING

Related Publications (3)

  • 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.

    PMID: 17351437BACKGROUND

  • O'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.

    PMID: 17631903RESULT

  • Brun-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.

    PMID: 15060765RESULT

Related Links

MeSH Terms

Conditions

BurnsInfections

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Oscar Penuelas, MD

    Critical Care Department and Burn Center. Hospital Universitario de Getafe, Madrid, Spain

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Oscar Penuelas, MD

CONTACT

0034-916834982openuelas@gmail.com

Miguel A De la Cal, MD

CONTACT

0034-916834982mcal@ucigetafe.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Attending of Critica Care Department and Burns Center, Hospital Universitario de Getafe

Study Record Dates

First Submitted

May 13, 2012

First Posted

May 23, 2012

Study Start

May 1, 2012

Primary Completion

June 1, 2014

Study Completion

December 1, 2014

Last Updated

August 29, 2012

Record last verified: 2012-05

Locations

ES(3)