Clinical trial NCT01243710: Taurolidine in Haemodialysis Catheter Related Bacteraemia
Official title: A Randomised Controlled Trial of Taurolidine With Heparin for Prevention of Recurrence of Catheter Related Bacteraemia in Haemodialysis Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Renal Dialysis
Catheter-Related Infections
Lead sponsor: Imperial College Healthcare NHS Trust
Sponsor class: OTHER
First posted: 2010-11-18
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Duration of bacteraemia-free catheter survival
timeFrame: Catheter survival measured up to six months from enrollment date.
Secondary outcomes:
measure: Catheter related flow problems
timeFrame: Catheter survival measured up to six months from enrollment date.
measure: Hospital admissions for catheter related problems including catheter removal
timeFrame: Catheter survival measured up to six months from enrollment date.
measure: Erythropoietin resistance
timeFrame: Catheter survival measured up to six months from enrollment date.
measure: Haemodialysis adequacy
timeFrame: Catheter survival measured up to six months from enrollment date.
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
Study officials:
affiliation: Imperial College Healthcare NHS Trust
name: Neill Duncan, MBBS
role: PRINCIPAL_INVESTIGATOR
References: