Taurolidine in Haemodialysis Catheter Related Bacteraemia

This study is currently recruiting participants.
Verified November 2010 by Imperial College Healthcare NHS Trust
Sponsor:
Information provided by:
Imperial College Healthcare NHS Trust
ClinicalTrials.gov Identifier:
NCT01243710
First received: November 17, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted

November 17, 2010
November 17, 2010
August 2010
August 2012   (final data collection date for primary outcome measure)
Duration of bacteraemia-free catheter survival [ Time Frame: Catheter survival measured up to six months from enrollment date. ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Catheter related flow problems [ Time Frame: Catheter survival measured up to six months from enrollment date. ] [ Designated as safety issue: No ]

    Quantified by use of:

    1. Urokinase locks
    2. Systemic urokinase infusions
  • Hospital admissions for catheter related problems including catheter removal [ Time Frame: Catheter survival measured up to six months from enrollment date. ] [ Designated as safety issue: No ]
  • Erythropoietin resistance [ Time Frame: Catheter survival measured up to six months from enrollment date. ] [ Designated as safety issue: No ]

    Quantified by:

    1. Erythropoietin dose
    2. Number of blood transfusions required
  • Haemodialysis adequacy [ Time Frame: Catheter survival measured up to six months from enrollment date. ] [ Designated as safety issue: No ]

    Quantified by:

    1. Kt/V
    2. Blood flows
Same as current
Not Provided
Not Provided
 
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.

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.

Infections related to long-term haemodialysis catheters are associated with significant morbidity. A high proportion of those people initially treated with antibiotics to clear a catheter infection develop a second infection within six months, necessitating the removal and replacement of the dialysis catheter.

This study will examine the efficacy of an antimicrobial catheter locking solution called taurolidine with heparin in preventing a second infection within six months of a significant infection. This solution will be compared with the solution used currently (heparin) which is left inside the catheter between dialysis sessions.

This is a clinical study given that antimicrobial catheter locks are thought to reduce the risk of blood stream infections and the ultimate need for catheter change. However, there is concern that the absence of an anticoagulant in the lock solution increases the risk of catheter thrombosis, again requiring a change of catheter but for a separate reason. It is unclear therefore whether a solution containing both taurolidine (an antimicrobial) and heparin (an anticoagulant) will increase catheter survival.

The results of this study will help guide the appropriate suse of locking solutions in the future.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Renal Dialysis
  • Catheter-Related Infections
Device: Taurolidine with heparin (500 units/ ml)
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.
Other Name: Taurolock Hep500
  • Experimental: Taurolidine with heparin
    Intervention: Device: Taurolidine with heparin (500 units/ ml)
  • Active Comparator: Heparin
    Intervention: Device: Taurolidine with heparin (500 units/ ml)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
August 2013
August 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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
  • All patients with a recent catheter related bacteraemia with an identified organism grown on microbiological culture and treated without catheter removal will be eligible for inclusion.

Exclusion Criteria:

  • 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.
Both
18 Years and older
No
Contact: Neill Duncan, MBBS +44 20 8383 5232 neill.duncan@imperial.nhs.uk
Contact: Richard W Corbett, BM BCh richard.corbett@imperial.nhs.uk
United Kingdom
 
NCT01243710
DUNN1007
No
Miss Becky Ward, AHSC Joint Research Office, Imperial College London and Imperial College Healthcare NHS Trust, St Mary's Hospital, Faculty of Medicine, Room GM14, Ground Mezzanine Floor, Praed Street, Wing London, W2 1PG
Imperial College Healthcare NHS Trust
Not Provided
Principal Investigator: Neill Duncan, MBBS Imperial College Healthcare NHS Trust
Imperial College Healthcare NHS Trust
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP