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
  Purpose

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.


Condition Intervention Phase
Bacteremia
Neoplasms
Device: Taurolock
Device: Heparin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Randomised Study of Taurolock for the Locking of Tunneled Central Venous Catheters in Children With Malignant Diseases.

Resource links provided by NLM:


Further study details as provided by Aarhus University Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 129
Study Start Date: April 2008
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Tunneled central venous catheters locked with Taurolock
Device: Taurolock
When not in use the childrens tunneled central venous catheters are locked with the liquid Taurolock instead of heparin.
Active Comparator: B
Tunneled central venous catheter locked with heparin
Device: Heparin
When not in use the childrens tunneled central venous catheters are locked with heparin

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00735813

Locations
Denmark
Childrens Department of Oncology A4, Aarhus Universityhospital, Skejby
Århus N, Denmark, 8200
Sponsors and Collaborators
Aarhus University Hospital
The Danish Child Cancer Foundation
TauroPharm
Investigators
Study Director: Henrik Schrøder, MD, Dr.med. Aarhus Universityhospital, Skejby
  More Information

Additional Information:
Publications:
Responsible Party: Mette Møller Handrup, MD, PhD, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT00735813     History of Changes
Other Study ID Numbers: 17344
Study First Received: August 14, 2008
Last Updated: September 4, 2012
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Aarhus University Hospital:
Catheterization, Central
Catheterization, Peripheral
Infection
Methods
Sepsis
Microscopy, Electron, Scanning
Sonication
Taurolidine
Catheters, Indwelling
Pediatrics

Additional relevant MeSH terms:
Bacteremia
Neoplasms
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Calcium heparin
Heparin
Taurolidine
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Infective Agents
Anti-Infective Agents, Local
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 28, 2014