Taurolidine in Haemodialysis Catheter Related Bacteraemia
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| First Received Date ICMJE | November 17, 2010 | ||||||||
| Last Updated Date | November 17, 2010 | ||||||||
| Start Date ICMJE | August 2010 | ||||||||
| Estimated Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Duration of bacteraemia-free catheter survival [ Time Frame: Catheter survival measured up to six months from enrollment date. ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Taurolidine in Haemodialysis Catheter Related Bacteraemia | ||||||||
| Official Title ICMJE | A Randomised Controlled Trial of Taurolidine With Heparin for Prevention of Recurrence of Catheter Related Bacteraemia in Haemodialysis Patients. | ||||||||
| 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. |
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| Detailed Description | 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | 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 |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 100 | ||||||||
| Estimated Completion Date | August 2013 | ||||||||
| Estimated Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United Kingdom | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01243710 | ||||||||
| Other Study ID Numbers ICMJE | DUNN1007 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | 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 | ||||||||
| Study Sponsor ICMJE | Imperial College Healthcare NHS Trust | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Imperial College Healthcare NHS Trust | ||||||||
| Verification Date | November 2010 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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