Taurolidine Lock Solution in the Prevention of Catheter Related Bacteremia
Primary Purpose
Bacteremia, Neoplasms
Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Taurolock
Heparin
Sponsored by
About this trial
This is an interventional prevention trial for Bacteremia focused on measuring Catheterization, Central, Catheterization, Peripheral, Infection, Methods, Sepsis, Microscopy, Electron, Scanning, Sonication, Taurolidine, Catheters, Indwelling, Pediatrics
Eligibility 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
Sites / Locations
- Childrens Department of Oncology A4, Aarhus Universityhospital, Skejby
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
A
B
Arm Description
Tunneled central venous catheters locked with Taurolock
Tunneled central venous catheter locked with heparin
Outcomes
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
Secondary Outcome Measures
Biofilm formation in the CVCs treated with Taurolock compared with the biofilm formation in the CVCs treated with heparin
Full Information
NCT ID
NCT00735813
First Posted
August 14, 2008
Last Updated
September 4, 2012
Sponsor
Aarhus University Hospital
Collaborators
Danish Child Cancer Foundation, TauroPharm
1. Study Identification
Unique Protocol Identification Number
NCT00735813
Brief Title
Taurolidine Lock Solution in the Prevention of Catheter Related Bacteremia
Official Title
A Randomised Study of Taurolock for the Locking of Tunneled Central Venous Catheters in Children With Malignant Diseases.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital
Collaborators
Danish Child Cancer Foundation, TauroPharm
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacteremia, Neoplasms
Keywords
Catheterization, Central, Catheterization, Peripheral, Infection, Methods, Sepsis, Microscopy, Electron, Scanning, Sonication, Taurolidine, Catheters, Indwelling, Pediatrics
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
129 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Tunneled central venous catheters locked with Taurolock
Arm Title
B
Arm Type
Active Comparator
Arm Description
Tunneled central venous catheter locked with heparin
Intervention Type
Device
Intervention Name(s)
Taurolock
Intervention Description
When not in use the childrens tunneled central venous catheters are locked with the liquid Taurolock instead of heparin.
Intervention Type
Device
Intervention Name(s)
Heparin
Intervention Description
When not in use the childrens tunneled central venous catheters are locked with heparin
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Biofilm formation in the CVCs treated with Taurolock compared with the biofilm formation in the CVCs treated with heparin
Time Frame
February 2010
10. Eligibility
Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henrik Schrøder, MD, Dr.med.
Organizational Affiliation
Aarhus Universityhospital, Skejby
Official's Role
Study Director
Facility Information:
Facility Name
Childrens Department of Oncology A4, Aarhus Universityhospital, Skejby
City
Århus N
ZIP/Postal Code
8200
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
18664870
Citation
Bradshaw JH, Puntis JW. Taurolidine and catheter-related bloodstream infection: a systematic review of the literature. J Pediatr Gastroenterol Nutr. 2008 Aug;47(2):179-86. doi: 10.1097/MPG.0b013e318162c428.
Results Reference
background
PubMed Identifier
14993498
Citation
Betjes MG, van Agteren M. Prevention of dialysis catheter-related sepsis with a citrate-taurolidine-containing lock solution. Nephrol Dial Transplant. 2004 Jun;19(6):1546-51. doi: 10.1093/ndt/gfh014. Epub 2004 Feb 19.
Results Reference
background
PubMed Identifier
17897607
Citation
Raad I, Hanna H, Maki D. Intravascular catheter-related infections: advances in diagnosis, prevention, and management. Lancet Infect Dis. 2007 Oct;7(10):645-57. doi: 10.1016/S1473-3099(07)70235-9.
Results Reference
background
PubMed Identifier
12517020
Citation
O'Grady NP, Alexander M, Dellinger EP, Gerberding JL, Heard SO, Maki DG, Masur H, McCormick RD, Mermel LA, Pearson ML, Raad II, Randolph A, Weinstein RA; Healthcare Infection Control Practices Advisory Committee. Guidelines for the prevention of intravascular catheter-related infections. Infect Control Hosp Epidemiol. 2002 Dec;23(12):759-69. doi: 10.1086/502007.
Results Reference
background
PubMed Identifier
14706968
Citation
Raad I, Hanna HA, Alakech B, Chatzinikolaou I, Johnson MM, Tarrand J. Differential time to positivity: a useful method for diagnosing catheter-related bloodstream infections. Ann Intern Med. 2004 Jan 6;140(1):18-25. doi: 10.7326/0003-4819-140-1-200401060-00007.
Results Reference
background
PubMed Identifier
23417891
Citation
Handrup MM, Moller JK, Schroder H. Central venous catheters and catheter locks in children with cancer: a prospective randomized trial of taurolidine versus heparin. Pediatr Blood Cancer. 2013 Aug;60(8):1292-8. doi: 10.1002/pbc.24482. Epub 2013 Feb 15.
Results Reference
derived
Links:
URL
http://www.taurolock.de
Description
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Taurolidine Lock Solution in the Prevention of Catheter Related Bacteremia
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