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Taurolidine in Haemodialysis Catheter Related Bacteraemia

Primary Purpose

Renal Dialysis, Catheter-Related Infections

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Taurolidine with heparin (500 units/ ml)
Sponsored by
Imperial College Healthcare NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Dialysis

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Imperial College Healthcare NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Taurolidine with heparin

Heparin

Arm Description

Outcomes

Primary Outcome Measures

Duration of bacteraemia-free catheter survival

Secondary Outcome Measures

Catheter related flow problems
Quantified by use of: Urokinase locks Systemic urokinase infusions
Hospital admissions for catheter related problems including catheter removal
Erythropoietin resistance
Quantified by: Erythropoietin dose Number of blood transfusions required
Haemodialysis adequacy
Quantified by: Kt/V Blood flows

Full Information

First Posted
November 17, 2010
Last Updated
July 29, 2020
Sponsor
Imperial College Healthcare NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT01243710
Brief Title
Taurolidine in Haemodialysis Catheter Related Bacteraemia
Official Title
A Randomised Controlled Trial of Taurolidine With Heparin for Prevention of Recurrence of Catheter Related Bacteraemia in Haemodialysis Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College Healthcare NHS Trust

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Dialysis, Catheter-Related Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Taurolidine with heparin
Arm Type
Experimental
Arm Title
Heparin
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Taurolidine with heparin (500 units/ ml)
Other Intervention Name(s)
Taurolock Hep500
Intervention Description
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.
Primary Outcome Measure Information:
Title
Duration of bacteraemia-free catheter survival
Time Frame
Catheter survival measured up to six months from enrollment date.
Secondary Outcome Measure Information:
Title
Catheter related flow problems
Description
Quantified by use of: Urokinase locks Systemic urokinase infusions
Time Frame
Catheter survival measured up to six months from enrollment date.
Title
Hospital admissions for catheter related problems including catheter removal
Time Frame
Catheter survival measured up to six months from enrollment date.
Title
Erythropoietin resistance
Description
Quantified by: Erythropoietin dose Number of blood transfusions required
Time Frame
Catheter survival measured up to six months from enrollment date.
Title
Haemodialysis adequacy
Description
Quantified by: Kt/V Blood flows
Time Frame
Catheter survival measured up to six months from enrollment date.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neill Duncan, MBBS
Organizational Affiliation
Imperial College Healthcare NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imperial College Healthcare NHS Trust
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom

12. IPD Sharing Statement

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Taurolidine in Haemodialysis Catheter Related Bacteraemia

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