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

Phase 4

Completed

• Conditions: End-stage Renal Disease; Catheter Infections
• Interventions: Device: TauroLock lock solution regimen; Device: 4% citrate lock solution regimen

• Registration Number: NCT02789501
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2016-05-25
• Study First Submitted QC: 2016-05-30
• Study First Posted: 2016-06-03
• Primary Completion: 2016-08
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-02
• Last Update Posted: 2016-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

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

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test	TauroLock lock solution regimen	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.
Control	4% citrate lock solution regimen	Non-systemic intraluminal application of 4% citrate lock solution (CitraFlow™ 4%, MedXL, Montreal, Canada) 3 times per week after dialysis.

Primary Outcome Measures

Name	Time	Method
Number of Catheter Related Blood Stream Infections (CRBSI)	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.

Secondary Outcome Measures

Name	Time	Method
Number of Catheter Dysfunctions (inadequate blood flow during dialysis, necessity of catheter rescue with alteplase)	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

Trial Locations

Locations (1)

Department of Medicine III, Division of Nephrology and Dialysis, Medical University of Vienna; 🇦🇹 Vienna, Austria