MedDataX Logo

Taurolidine Lock Solution in the Prevention of Catheter Related Bacteremia

NCT ID: NCT00735813

Last Updated: 2012-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2012-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bacteremia Neoplasms

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Catheterization, Central Catheterization, Peripheral Infection Methods Sepsis Microscopy, Electron, Scanning Sonication Taurolidine Catheters, Indwelling Pediatrics

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

Tunneled central venous catheters locked with Taurolock

Group Type EXPERIMENTAL

Taurolock

Intervention Type DEVICE

When not in use the childrens tunneled central venous catheters are locked with the liquid Taurolock instead of heparin.

B

Tunneled central venous catheter locked with heparin

Group Type ACTIVE_COMPARATOR

Heparin

Intervention Type DEVICE

When not in use the childrens tunneled central venous catheters are locked with heparin

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Taurolock

When not in use the childrens tunneled central venous catheters are locked with the liquid Taurolock instead of heparin.

Intervention Type DEVICE

Heparin

When not in use the childrens tunneled central venous catheters are locked with heparin

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Danish Child Cancer Foundation

OTHER

Sponsor Role collaborator

TauroPharm

INDUSTRY

Sponsor Role collaborator

Aarhus University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mette Møller Handrup

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Henrik Schrøder, MD, Dr.med.

Role: STUDY_DIRECTOR

Aarhus Universityhospital, Skejby

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Childrens Department of Oncology A4, Aarhus Universityhospital, Skejby

Århus N, , Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 18664870 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14993498 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17897607 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12517020 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14706968 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23417891 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://www.taurolock.de

Related Info

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

17344

Identifier Type: -

Identifier Source: org_study_id