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NCT Number: NCT02789501

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.

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Key information

Conditions

Catheter Infections Chronic Disease Disease Attributes End-stage Renal Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Vienna, State of Vienna, 1180, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

4% citrate lock solution regimen

Device

(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™

TauroLock lock solution regimen

Device

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™

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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:

    • 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

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2016
First posted
Jun 3, 2016
Registry last updated
Dec 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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