Taurolidine in Haemodialysis Catheter Related Bacteraemia

Renal Dialysis Clinical Trial

Official title:

A Randomised Controlled Trial of Taurolidine With Heparin for Prevention of Recurrence of Catheter Related Bacteraemia in Haemodialysis Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01243710
• Other study ID #: DUNN1007
• Status: Completed
• Phase: Phase 4
• Start date: August 2010
• Est. completion date: December 2012

Study information

• Verified date: July 2020
• Source: Imperial College Healthcare NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bacteremia
• Catheter-Related Infections
• Renal Dialysis

Intervention

Device:
• Taurolidine 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.

Locations

Country	Name	City	State
United Kingdom	Imperial College Healthcare NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College Healthcare NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of bacteraemia-free catheter survival		Catheter survival measured up to six months from enrollment date.
Secondary	Catheter related flow problems	Quantified by use of: Urokinase locks; Systemic urokinase infusions	Catheter survival measured up to six months from enrollment date.
Secondary	Hospital admissions for catheter related problems including catheter removal		Catheter survival measured up to six months from enrollment date.
Secondary	Erythropoietin resistance	Quantified by: Erythropoietin dose; Number of blood transfusions required	Catheter survival measured up to six months from enrollment date.
Secondary	Haemodialysis adequacy	Quantified by: Kt/V; Blood flows	Catheter survival measured up to six months from enrollment date.