Taurolidine in Haemodialysis Catheter Related Bacteraemia

Imperial College Healthcare NHS Trust

Status and phase

Completed

Phase 4

Conditions

Catheter-Related Infections

Renal Dialysis

Treatments

Device: Taurolidine with heparin (500 units/ ml)

Study type

Interventional

Funder types

Other

Identifiers

NCT01243710

DUNN1007

Details and patient eligibility

About

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.

Full 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.

Enrollment

27 patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

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.