Taurolidine in Haemodialysis Catheter Related Bacteraemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Imperial College Healthcare NHS Trust
ClinicalTrials.gov Identifier:
NCT01243710
First received: November 17, 2010
Last updated: August 14, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Renal Dialysis
Catheter-Related Infections
Device: Taurolidine with heparin (500 units/ ml)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial of Taurolidine With Heparin for Prevention of Recurrence of Catheter Related Bacteraemia in Haemodialysis Patients.

Resource links provided by NLM:


Further study details as provided by Imperial College Healthcare NHS Trust:

Primary Outcome Measures:
  • Duration of bacteraemia-free catheter survival [ Time Frame: Catheter survival measured up to six months from enrollment date. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Catheter related flow problems [ Time Frame: Catheter survival measured up to six months from enrollment date. ] [ Designated as safety issue: No ]

    Quantified by use of:

    1. Urokinase locks
    2. Systemic urokinase infusions

  • Hospital admissions for catheter related problems including catheter removal [ Time Frame: Catheter survival measured up to six months from enrollment date. ] [ Designated as safety issue: No ]
  • Erythropoietin resistance [ Time Frame: Catheter survival measured up to six months from enrollment date. ] [ Designated as safety issue: No ]

    Quantified by:

    1. Erythropoietin dose
    2. Number of blood transfusions required

  • Haemodialysis adequacy [ Time Frame: Catheter survival measured up to six months from enrollment date. ] [ Designated as safety issue: No ]

    Quantified by:

    1. Kt/V
    2. Blood flows


Enrollment: 27
Study Start Date: August 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Taurolock Hep500

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01243710

Locations
United Kingdom
Imperial College Healthcare NHS Trust
London, United Kingdom, W12 0HS
Sponsors and Collaborators
Imperial College Healthcare NHS Trust
Investigators
Principal Investigator: Neill Duncan, MBBS Imperial College Healthcare NHS Trust
  More Information

No publications provided

Responsible Party: Imperial College Healthcare NHS Trust
ClinicalTrials.gov Identifier: NCT01243710     History of Changes
Other Study ID Numbers: DUNN1007
Study First Received: November 17, 2010
Last Updated: August 14, 2013
Health Authority: United Kingdom: National Health Service

Additional relevant MeSH terms:
Bacteremia
Catheter-Related Infections
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Calcium heparin
Heparin
Taurolidine
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Infective Agents, Local
Anti-Infective Agents
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 29, 2014