Taurolidine Lock Solution in the Prevention of Catheter Related Bacteremia

This study has been completed.
Sponsor:
Collaborators:
The Danish Child Cancer Foundation
TauroPharm
Information provided by (Responsible Party):
Mette Møller Handrup, Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT00735813
First received: August 14, 2008
Last updated: September 4, 2012
Last verified: September 2012

August 14, 2008
September 4, 2012
April 2008
September 2012   (final data collection date for primary outcome measure)
Number of catheter related blood stream infections(CRBSI)in the Taurolock group vs the heparin group. Number of CRBSI/1000 CVC days in the Taurolock group vs the heparin group. Number of CVCs removed in the Taurolock group vs the heparin group [ Time Frame: November 2010 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00735813 on ClinicalTrials.gov Archive Site
Biofilm formation in the CVCs treated with Taurolock compared with the biofilm formation in the CVCs treated with heparin [ Time Frame: February 2010 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Taurolidine Lock Solution in the Prevention of Catheter Related Bacteremia
A Randomised Study of Taurolock for the Locking of Tunneled Central Venous Catheters in Children With Malignant Diseases.

Children with cancer need a long term tunnelled central venous catheter (TCVC) for the entire duration of their treatment. TCVCs are locked with heparin when not in use. The most frequent complications of long term TCVC are catheter related blood steam infections. Taurolock is a new lock that is claimed to prevent the formation of luminal biofilm in TCVCs and has been demonstrated to eradicate infected CVCs. In this study the investigators will compare TCVCs locked with heparin with TCVCs locked with Taurolock. Hypothesis: Taurolock will diminish the number of CRBSI in children with cancer compared with children with heparin lock of their CVC.

The most frequent complications of long term TCVC are catheter related blood steam infections(CRBSI)often caused by microorganisms located in the biofilm formed on the inner surface of the TCVC after a short time. CRBSI may be lifethreatening, will need long term intravenous broad spectrum antibiotic therapy possibly combined with intraluminal antibiotic lock therapy. In spite of this CRBSI may often lead to the premature removal of the TCVC.

Several methods to prevent the occurrence of intraluminal microbial colonization have been investigated with no single method standing out as the optimal one.

There is a need for a simple and safe method of reducing the occurrence of CRBSI in immunocompromised children receiving chemotherapy for malignant diseases. Various catheter lock solutions in stead of using heparin have been investigated in experimental models. Taurolidine is a chemically modified amino acid with broad spectrum antimicrobial activity in vitro. It is claimed to prevent the formation of luminal biofilm in TCVCs in a CVC model and it has been demonstrated to eradicate infected CVC in a three reports with a total of 18 patients.

In a 24 months study of routine use of Taurolidine 1,25%/Sodium-Citrate 4% (TaurolockTM) a reduction of gram-positive CVC associated infections was demonstrated. The findings were not statistically significant due to relatively few patients.

There is a need of a larger study with more patients receiving Taurolock for locking the TCVC between use in order to test for a significant reduction of the occurrence of CRBSI. Furthermore there is a need for an in vivo demonstration of the reduction of biofilm formation in TCVCs locked with taurolock compared with TCVCs locked with heparin.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Bacteremia
  • Neoplasms
  • Device: Taurolock
    When not in use the childrens tunneled central venous catheters are locked with the liquid Taurolock instead of heparin.
  • Device: Heparin
    When not in use the childrens tunneled central venous catheters are locked with heparin
  • Experimental: A
    Tunneled central venous catheters locked with Taurolock
    Intervention: Device: Taurolock
  • Active Comparator: B
    Tunneled central venous catheter locked with heparin
    Intervention: Device: Heparin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
129
September 2012
September 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Children aged 0-17 years with malignant disease requiring a tunneled central venous catheter.

Exclusion Criteria:

  • No written consent from child or parents
Both
up to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00735813
17344
No
Mette Møller Handrup, Aarhus University Hospital
Aarhus University Hospital
  • The Danish Child Cancer Foundation
  • TauroPharm
Study Director: Henrik Schrøder, MD, Dr.med. Aarhus Universityhospital, Skejby
Aarhus University Hospital
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP