Taurolidine Lock Solution in the Prevention of Catheter R... | NCT00735813

Studies
Taurolidine Lock Solution in the Prevention of Catheter Related Bacteremia

NCT00735813

Sponsor

Aarhus University Hospital

Status

Completed

Last Update Posted

Sep 5, 2012Estimated

Enrollment

129Actual

Phase

Phase 3

Conditions

Bacteremia
Neoplasms

Interventions

Taurolock
Heparin

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

Sep 2012Actual

Completion Date

Sep 2012Actual

First Submitted Date

Aug 14, 2008

First Submission Date that Met QC Criteria

Aug 14, 2008

First Posted Date

Aug 15, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 4, 2012

Last Update Posted Date

Sep 5, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mette Møller Handrup, MD, PhD, Aarhus University HospitalPrincipal Investigator

Lead Sponsor

Aarhus University HospitalOTHER

Collaborators

Name	Class
Danish Child Cancer Foundation	OTHER
TauroPharm	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

129Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	Tunneled central venous catheters locked with Taurolock	Device: Taurolock
B	Active Comparator	Tunneled central venous catheter locked with heparin	Device: Heparin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Taurolock	Device	When not in use the childrens tunneled central venous catheters are locked with the liquid Taurolock instead of heparin.	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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		November 2010

Secondary Outcomes

Measure	Description	Time Frame
Biofilm formation in the CVCs treated with Taurolock compared with the biofilm formation in the CVCs treated with heparin		February 2010

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Henrik Schrøder, MD, Dr.med.	Aarhus Universityhospital, Skejby	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Childrens Department of Oncology A4, Aarhus Universityhospital, Skejby		Århus N		8200	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18664870	Background	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.
14993498	Background	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.

ID	Term
D016470	Bacteremia
D009369	Neoplasms
D007239	Infections
D018805	Sepsis

ID	Term
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation