Taurolidine in Haemodialysis Catheter Related Bacteraemia
A Randomised Controlled Trial of Taurolidine With Heparin for Prevention of Recurrence of Catheter Related Bacteraemia in Haemodialysis Patients.
1 other identifier
interventional
27
1 country
1
Brief Summary
The purpose of this study is to determine whether taurolidine with heparin locking solution prevents recurrence of central venous catheter related blood stream infections in haemodialysis patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Aug 2010
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 17, 2010
CompletedFirst Posted
Study publicly available on registry
November 18, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedJuly 30, 2020
July 1, 2020
2.3 years
November 17, 2010
July 29, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Duration of bacteraemia-free catheter survival
Catheter survival measured up to six months from enrollment date.
Secondary Outcomes (4)
Catheter related flow problems
Catheter survival measured up to six months from enrollment date.
Hospital admissions for catheter related problems including catheter removal
Catheter survival measured up to six months from enrollment date.
Erythropoietin resistance
Catheter survival measured up to six months from enrollment date.
Haemodialysis adequacy
Catheter survival measured up to six months from enrollment date.
Study Arms (2)
Taurolidine with heparin
EXPERIMENTALHeparin
ACTIVE COMPARATORInterventions
Central venous catheter will be locked (the designated volume required to fill the dead space) with taurolidine with heparin after each dialysis session. The control arm will be locked with heparin as is current practice.
Eligibility Criteria
You may qualify if:
- Haemodialysis patients established on dialysis for greater than 90 days who dialyse in-centre at any of the satellite dialysis units of Imperial College Healthcare NHS Trust
You may not qualify if:
- Those individuals in whom attempted catheter salvage is clinically not indicated.
- Unable to provide informed consent
- Known allergy to sodium citrate, heparin or taurolidine.
- Bleeding diathesis or physical cause for active bleeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Imperial College Healthcare NHS Trust
London, W12 0HS, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Neill Duncan, MBBS
Imperial College Healthcare NHS Trust
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2010
First Posted
November 18, 2010
Study Start
August 1, 2010
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
July 30, 2020
Record last verified: 2020-07