Imperial College Healthcare NHS Trust
London, W12 0HS, United Kingdom
NCT Number: NCT01243710
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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Notify Me18 year–120 year
All sexes
Interventional
Phase 4
London, W12 0HS, United Kingdom
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 names: Taurolock Hep500
Time frame: Catheter survival measured up to six months from enrollment date.
Time frame: Catheter survival measured up to six months from enrollment date.
Quantified by use of:
Time frame: Catheter survival measured up to six months from enrollment date.
Time frame: Catheter survival measured up to six months from enrollment date.
Quantified by:
Time frame: Catheter survival measured up to six months from enrollment date.
Quantified by:
Imperial College Healthcare NHS Trust
Other
A Randomised Controlled Trial of Taurolidine With Heparin for Prevention of Recurrence of Catheter Related Bacteraemia in Haemodialysis Patients.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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