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ISRCTN
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ISRCTN13630682
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ClinicalTrials.gov identifier
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Public title
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A randomised controlled trial comparing taurolidine-citrate with heparin for locking tunnelled haemodialysis catheters
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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A new catheter-locking solution containing taurolodine and citrate has been shown to reduce catheter-related bacteraemia in small studies of mainly non-tunnelled catheters. We aim to test whether use of this solution will reduce the incidence of catheter-related bacteraemia in patients with tunnelled dialysis catheters.
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Lay summary
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Ethics approval
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Medical Research Ethics Committee for Scotland A (reference: 06/MRE00/43), approval received 13/06/2006.
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Study design
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Interventional randomised double-blind controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Chronic Renal Failure requiring treatment with regular haemodialysis
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Participants - inclusion criteria
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1. Chronic renal failure requiring haemodialysis
2. Patients undergoing tunnelled haemodialysis catheter insertion
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Participants - exclusion criteria
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1. Aged under 16 years
2. Known intolerance to heparin or taurolidine-citrate
3. Patients receiving antibiotic treatment
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Anticipated start date
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01/10/2006
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Anticipated end date
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01/10/2008
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Status of trial
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Stopped |
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Patient information material
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Target number of participants
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164
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Interventions
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One group will be randomised to receive taurolidine-citrate catheter lock solution and the other heparin 5000 iu/ml catheter lock solution.
Added 18/02/2010: trial was stopped because objectives were no longer viable.
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Primary outcome measure(s)
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Rates of catheter-related bacteraemia
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Secondary outcome measure(s)
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1. Rates of catheter occlusion
2. Mortality rate
3. Exit-site infection rates
4. Epoietin requirements
5. Hospitalisation
6. Haemodialysis adequacy
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Sources of funding
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Glasgow Royal Infirmary Renal Unit Research Fund (UK)
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Trial website
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Publications
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Contact name
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Dr
Scott
Morris
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Address
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Renal Unit
3rd Floor Walton Building
Glasgow Royal Infirmary
84 Castle Street
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City/town
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Glasgow
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Zip/Postcode
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G4 0SF
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Country
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United Kingdom
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Sponsor
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North Glasgow University NHS Division (UK)
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Address
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Greater Glasgow Health Board
c/o Dr Fiona Graham
East Research and Development Office
4th Floor Walton Building
Glasgow Royal Infirmary
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City/town
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Glasgow
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Zip/Postcode
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G4 0SF
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Country
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United Kingdom
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Date applied
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04/07/2006
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Last edited
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18/02/2010
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Date ISRCTN assigned
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21/09/2006
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