Comparison of a TauroLock™ Based Regimen to 4% Citrate as Lock Solution in Tunneled Haemodialysis Catheters for the Prevention of Bacteraemia and Dysfunction

December 2, 2016 updated by: Guerkan SENGOELGE, Medical University of Vienna

Prospective Trial for Comparison of a TauroLock™ Based Regimen to 4% Citrate as Lock Solution in Tunneled Haemodialysis Catheters for the Prevention of Bacteraemia and Dysfunction

Catheter infections and dysfunctions are a major cause of morbidity and mortality in haemodialysis patients. According to the US Renal Data System, infection is the second leading cause of death in dialysis patients and the leading cause of catheter removal and morbidity in patients with end-stage renal disease.

There is evidence that catheter lock solutions containing taurolidine reduce the risk of catheter related infections and improve catheter patency. Lock solutions have a local, but no systemic effect. In this study a taurolidine based lock regimen (TauroLock™-Hep500, Tauropharm, Waldbüttelbrunn, Germany, 2x/week and TauroLock™-U25.000, Tauropharm, Waldbüttelbrunn, Germany, 1x/ week) will be compared to 4% citrate (CitraFlow™ 4%, MedXL, Montreal, Canada, 3x/week) as standard lock solution.

The objective of this study is to evaluate if a TauroLock™ based regimen to lock tunneled haemodialysis catheters has reducing effects on catheter related blood stream infections and catheter dysfunctions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

106

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

  • Austria
      • Vienna, Austria, 1180
        • Department of Medicine III, Division of Nephrology and Dialysis, Medical University of Vienna

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients aged greater than 18 years.
  • Written informed consent.
  • Requirement for haemodialysis using a tunneled dialysis catheter.

Exclusion Criteria:

  • Children aged less than 18 years.
  • Positive blood culture in previous seven days before catheter insertion.
  • Heparin induced thrombocytopenia and any contraindication for anticoagulation (recent or planned surgery, thrombocytopenia < 70G/l, bleeding disorder).

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Non-systemic intraluminal application of 4% citrate lock solution (CitraFlow™ 4%, MedXL, Montreal, Canada) 3 times per week after dialysis.
Device: 4% citrate lock solution regimen
(CitraFlow™ 4%, MedXL, Montreal, Canada) will be injected in each of the 2 lumens of the tunneled catheters after each dialysis session (2ml/lumen, 3x/week).
Other Names:
  • CitraFlow™
Experimental: Test

TauroLock™ based lock solution regimen:

Non-systemic intraluminal application of TauroLock™-Hep500, Tauropharm, Waldbüttelbrunn, Germany, 2x/week after dialysis (before short intervals) and TauroLock™-U25.000, Tauropharm, Waldbüttelbrunn, Germany, 1x/ week after dialysis (before long interval).

TauroLock™-Hep500 contains 1% (cyclo)-taurolidine, 4% citrate and 500 IU/mL heparin.

TauroLock™-U25.000 contains 1% (cyclo)-taurolidine, 4% citrate and 25.000 IU urokinase.
Device: TauroLock lock solution regimen
After the first two dialysis sessions of the week (before the short intervals) 2 ml of TauroLock™-Hep500 containing 1% (cyclo)-taurolidine, 4% citrate and 500 IU/mL heparin will be injected into each of the two lumens of the tunneled catheter. After the third dialysis of the week, thus before the long interval, 2 ml of TauroLock™-U25.000 which contains 1% (cyclo)-taurolidine, 4% citrate and 25.000 IU urokinase will be applied into each lumen.
Other Names:
  • TauroLock™-Hep500™
  • TauroLock™-U25.000™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Catheter Related Blood Stream Infections (CRBSI)
Time Frame: from insertion of the tunneled catheter through study completion, an average of 1 year
Catheter related blood stream infections are defined as infections in patients with tunneled dialysis catheters with a recognized pathogen cultured from blood cultures with no other source of infection.
from insertion of the tunneled catheter through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Catheter Dysfunctions (inadequate blood flow during dialysis, necessity of catheter rescue with alteplase)
Time Frame: from insertion of the tunneled catheter through study completion, an average of 1 year

catheter function/dysfunction will be assessed during each dialysis session.

Parameters to assess catheter dysfunctions numerically are:

  1. blood flow during dialysis - inadequate blood flow is defined as blood flow < 200ml/min or >30% less than the average of the previous 10 dialysis sessions
  2. necessity of catheter rescue with alteplase
from insertion of the tunneled catheter through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Guerkan Sengoelge, MD, Medical University of Vienna, Department of Medicine III, Division of Nephrology and Dialysis

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

January 1, 2012

Primary Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

May 25, 2016

First Submitted That Met QC Criteria

May 30, 2016

First Posted (Estimate)

June 3, 2016

Study Record Updates

Last Update Posted (Estimate)

December 5, 2016

Last Update Submitted That Met QC Criteria

December 2, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Vienna CathLock-Study

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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