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

End-stage Renal Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02789501
• Other study ID #: Vienna CathLock-Study
• Status: Completed
• Phase: Phase 4
• First received: May 25, 2016
• Last updated: December 2, 2016
• Start date: January 2012

Study information

• Verified date: December 2016
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bacteremia
• Catheter Infections
• End-stage Renal Disease
• Kidney Failure, Chronic

Intervention

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).
• 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.

Locations

Country	Name	City	State
Austria	Department of Medicine III, Division of Nephrology and Dialysis, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	from insertion of the tunneled catheter through study completion, an average of 1 year	No
Secondary	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	from insertion of the tunneled catheter through study completion, an average of 1 year	No