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Taurolidine in Haemodialysis Catheter Related Bacteraemia

Sponsor
Imperial College Healthcare NHS Trust (Other)
Overall Status
Completed
CT.gov ID
NCT01243710
Collaborator
(none)
27
Enrollment
1
Location
2
Arms
28
Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Taurolidine with heparin (500 units/ ml)
 Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
27 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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.
Study Start Date :
Aug 1, 2010
Actual Primary Completion Date :
Dec 1, 2012
Actual Study Completion Date :
Dec 1, 2012

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Duration of bacteraemia-free catheter survival [Catheter survival measured up to six months from enrollment date.]

    Secondary Outcome Measures

    1. Catheter related flow problems [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 [Catheter survival measured up to six months from enrollment date.]

    3. Erythropoietin resistance [Catheter survival measured up to six months from enrollment date.]

      Quantified by: Erythropoietin dose Number of blood transfusions required

    4. Haemodialysis adequacy [Catheter survival measured up to six months from enrollment date.]

      Quantified by: Kt/V Blood flows

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 120 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Imperial College Healthcare NHS Trust
    ClinicalTrials.gov Identifier:
    NCT01243710
    Other Study ID Numbers:
    • DUNN1007
    First Posted:
    Nov 18, 2010
    Last Update Posted:
    Jul 30, 2020
    Last Verified:
    Jul 1, 2020
    Additional relevant MeSH terms:
    Bacteremia
    Catheter-Related Infections
    Taurolidine
    Heparin

    Study Results

    No Results Posted as of Jul 30, 2020