Catheter-Related Infections, Renal Dialysis
Conditions
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.
Interventions
DEVICETaurolidine 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.
Sponsors
Imperial College Healthcare NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of bacteraemia-free catheter survival | Catheter survival measured up to six months from enrollment date. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital admissions for catheter related problems including catheter removal | Catheter survival measured up to six months from enrollment date. | — |
| Erythropoietin resistance | Catheter survival measured up to six months from enrollment date. | Quantified by: 1. Erythropoietin dose 2. Number of blood transfusions required |
| Haemodialysis adequacy | Catheter survival measured up to six months from enrollment date. | Quantified by: 1. Kt/V 2. Blood flows |
| Catheter related flow problems | Catheter survival measured up to six months from enrollment date. | Quantified by use of: 1. Urokinase locks 2. Systemic urokinase infusions |
Countries
United Kingdom
Outcome results
None listed