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Completed

NCT Number: NCT01243710

Taurolidine in Haemodialysis Catheter Related Bacteraemia

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.

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Key information

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Imperial College Healthcare NHS Trust

London, W12 0HS, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Taurolock Hep500

Primary outcomes

  1. Duration of bacteraemia-free catheter survival

    Time frame: Catheter survival measured up to six months from enrollment date.

Secondary outcomes

  1. Catheter related flow problems

    Time frame: Catheter survival measured up to six months from enrollment date.

    Quantified by use of:

    • Urokinase locks
    • Systemic urokinase infusions
  2. Hospital admissions for catheter related problems including catheter removal

    Time frame: Catheter survival measured up to six months from enrollment date.

  3. Erythropoietin resistance

    Time frame: Catheter survival measured up to six months from enrollment date.

    Quantified by:

    • Erythropoietin dose
    • Number of blood transfusions required
  4. Haemodialysis adequacy

    Time frame: Catheter survival measured up to six months from enrollment date.

    Quantified by:

    • Kt/V
    • Blood flows

Sponsors and collaborators

Lead sponsor

Imperial College Healthcare NHS Trust

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Nov 18, 2010
Registry last updated
Jul 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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