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

Primary Purpose

Catheter Infections, End-stage Renal Disease

Status
Completed
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
4% citrate lock solution regimen
TauroLock lock solution regimen
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Catheter Infections focused on measuring Catheter, Dysfunctions, Blood Stream Infections, Haemodialysis, Taurolidine, Tunneled

Eligibility Criteria

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

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).

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Test

Arm Description

Non-systemic intraluminal application of 4% citrate lock solution (CitraFlow™ 4%, MedXL, Montreal, Canada) 3 times per week after dialysis.

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.

Outcomes

Primary Outcome Measures

Number of Catheter Related Blood Stream Infections (CRBSI)
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.

Secondary Outcome Measures

Number of Catheter Dysfunctions (inadequate blood flow during dialysis, necessity of catheter rescue with alteplase)
catheter function/dysfunction will be assessed during each dialysis session. Parameters to assess catheter dysfunctions numerically are: 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 necessity of catheter rescue with alteplase

Full Information

First Posted
May 25, 2016
Last Updated
December 2, 2016
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT02789501
Brief Title
Comparison of a TauroLock™ Based Regimen to 4% Citrate as Lock Solution in Tunneled Haemodialysis Catheters for the Prevention of Bacteraemia and Dysfunction
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Catheter Infections, End-stage Renal Disease
Keywords
Catheter, Dysfunctions, Blood Stream Infections, Haemodialysis, Taurolidine, Tunneled

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
Non-systemic intraluminal application of 4% citrate lock solution (CitraFlow™ 4%, MedXL, Montreal, Canada) 3 times per week after dialysis.
Arm Title
Test
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
4% citrate lock solution regimen
Other Intervention Name(s)
CitraFlow™
Intervention Description
(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).
Intervention Type
Device
Intervention Name(s)
TauroLock lock solution regimen
Other Intervention Name(s)
TauroLock™-Hep500™, TauroLock™-U25.000™
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Catheter Related Blood Stream Infections (CRBSI)
Description
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.
Time Frame
from insertion of the tunneled catheter through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Number of Catheter Dysfunctions (inadequate blood flow during dialysis, necessity of catheter rescue with alteplase)
Description
catheter function/dysfunction will be assessed during each dialysis session. Parameters to assess catheter dysfunctions numerically are: 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 necessity of catheter rescue with alteplase
Time Frame
from insertion of the tunneled catheter through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guerkan Sengoelge, MD
Organizational Affiliation
Medical University of Vienna, Department of Medicine III, Division of Nephrology and Dialysis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medicine III, Division of Nephrology and Dialysis, Medical University of Vienna
City
Vienna
ZIP/Postal Code
1180
Country
Austria

12. IPD Sharing Statement

Learn more about this trial

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

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