Comparison of a TauroLock™ Based Regimen to 4% Citrate as Lock Solution in Tunneled Haemodialysis… (NCT02789501) | Clinical Trial Compass
CompletedPhase 4
Comparison of a TauroLock™ Based Regimen to 4% Citrate as Lock Solution in Tunneled Haemodialysis Catheters for the Prevention of Bacteraemia and Dysfunction
Austria106 participantsStarted 2012-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Catheter Related Blood Stream Infections (CRBSI)
Timeframe: from insertion of the tunneled catheter through study completion, an average of 1 year