Taurolidine in Haemodialysis Catheter Related Bacteraemia

Phase 4

Completed

• Conditions: Renal Dialysis; Catheter-Related Infections
• Interventions: Device: Taurolidine with heparin (500 units/ ml)

• Registration Number: NCT01243710
• Lead Sponsor: Imperial College Healthcare NHS Trust

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.

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-11-17
• Study First Submitted QC: 2010-11-17
• Study First Posted: 2010-11-18
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-29
• Last Update Posted: 2020-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Taurolidine with heparin	Taurolidine with heparin (500 units/ ml)	-
Heparin	Taurolidine with heparin (500 units/ ml)	-

Primary Outcome Measures

Name	Time	Method
Duration of bacteraemia-free catheter survival	Catheter survival measured up to six months from enrollment date.

Secondary Outcome Measures

Name	Time	Method
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
Haemodialysis adequacy	Catheter survival measured up to six months from enrollment date.	Quantified by: 1. Kt/V; 2. Blood flows
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

Trial Locations

Locations (1)

Imperial College Healthcare NHS Trust; 🇬🇧 London, United Kingdom