Taurolidine in Haemodialysis Catheter Related Bacteraemia

July 29, 2020 updated by: Imperial College Healthcare NHS Trust

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, W12 0HS
        • Imperial College Healthcare NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Taurolidine with heparin
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.
Other Names:
  • Taurolock Hep500
ACTIVE_COMPARATOR: Heparin
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.
Other Names:
  • Taurolock Hep500

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Duration of bacteraemia-free catheter survival
Time Frame: Catheter survival measured up to six months from enrollment date.
Catheter survival measured up to six months from enrollment date.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Catheter related flow problems
Time Frame: Catheter survival measured up to six months from enrollment date.

Quantified by use of:

  1. Urokinase locks
  2. Systemic urokinase infusions
Catheter survival measured up to six months from enrollment date.
Hospital admissions for catheter related problems including catheter removal
Time Frame: Catheter survival measured up to six months from enrollment date.
Catheter survival measured up to six months from enrollment date.
Erythropoietin resistance
Time Frame: Catheter survival measured up to six months from enrollment date.

Quantified by:

  1. Erythropoietin dose
  2. Number of blood transfusions required
Catheter survival measured up to six months from enrollment date.
Haemodialysis adequacy
Time Frame: Catheter survival measured up to six months from enrollment date.

Quantified by:

  1. Kt/V
  2. Blood flows
Catheter survival measured up to six months from enrollment date.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College Healthcare NHS Trust

Investigators

  • Principal Investigator: Neill Duncan, MBBS, Imperial College Healthcare NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

November 17, 2010

First Submitted That Met QC Criteria

November 17, 2010

First Posted (ESTIMATE)

November 18, 2010

Study Record Updates

Last Update Posted (ACTUAL)

July 30, 2020

Last Update Submitted That Met QC Criteria

July 29, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DUNN1007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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