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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Taurolidine with heparin | Experimental |
| |
| Heparin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Taurolidine with heparin (500 units/ ml) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of bacteraemia-free catheter survival | Catheter survival measured up to six months from enrollment date. |
| Measure | Description | Time Frame |
|---|---|---|
| Catheter related flow problems | Quantified by use of:
| Catheter survival measured up to six months from enrollment date. |
| Hospital admissions for catheter related problems including catheter removal |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neill Duncan, MBBS | Imperial College Healthcare NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College Healthcare NHS Trust | London | W12 0HS | United Kingdom |
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| ID | Term |
|---|---|
| D055499 | Catheter-Related Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
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|
| Catheter survival measured up to six months from enrollment date. |
| Erythropoietin resistance | Quantified by:
| Catheter survival measured up to six months from enrollment date. |
| Haemodialysis adequacy | Quantified by:
| Catheter survival measured up to six months from enrollment date. |