Prevention of Dialysis Catheter Malfunction With Prophylactic Use of a Taurolidine Containing Urokinase

Infection Clinical Trial

Official title:

Prevention of Tunneled Cuffed Catheter Malfunction With Prophylactic Use of a Taurolidine Locking Solution Containing Urokinase : a Multicentric Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02036255
• Other study ID #: TL-001
• Status: Completed
• Phase: Phase 3
• Start date: May 2015
• Est. completion date: May 2018

Study information

• Verified date: May 2018
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of our study is to investigate whether the substitution of the standard locking solution with a locking solution containing taurolidine and urokinase weekly (Taurolock ™ U 25,000 - www.taurolock.com ) reduces the rate of catheter dysfunction in hemodialysis patients with a history of TCC dysfunction requiring urokinase therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: May 2018
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Adult, prevalent hemodialysis patients

• Informed and consented

• Hemodialysis 3x/week via a tunneled cuffed catheter

• Urokinase administration at least two times during the previous 6 months (with more than a week between 2 administrations)

• Adequate catheter function during the week before inclusion (defined by blood flow more than 250ml/min on each dialysis session and blood flow within 15% of the maximal blood flow after the last Urokinase administration)

Exclusion Criteria:

• Presence of heparin-induced thrombocytopenia

• Major hemorrhage or intracranial bleeding in the previous 3 months

• Pericarditis

• Intolerance to Taurolidine, citrate or to Urokinase

• Active catheter-related infection

• Catheter in the femoral vein

Related Conditions & MeSH terms

• Infection
• Patency

Intervention

Drug:
• Taurolidine Urokinase

• Taurolidine Heparin

Locations

Country	Name	City	State
Belgium	Bracops Hospital	Anderlecht	Brussels
Belgium	UZ Antwerpen	Antwerpen
Belgium	Ixelles Hospital	Brussels
Belgium	CHU Charleroi	Charleroi	Hainaut
Belgium	Ghent Hospital	Ghent
Belgium	Ixelles Hospital	Ixelles	Brussels
Belgium	Brugman Hospital	Jette	Brussels
Belgium	Universitair Ziekenhuis Brussel	Jette	Brussels
Belgium	CHWAPI	Tournai	Hainaut

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

References & Publications (3)

Di Iorio BR, Bellizzi V, Cillo N, Cirillo M, Avella F, Andreucci VE, De Santo NG. Vascular access for hemodialysis: the impact on morbidity and mortality. J Nephrol. 2004 Jan-Feb;17(1):19-25. — View Citation

Hemmelgarn BR, Moist LM, Lok CE, Tonelli M, Manns BJ, Holden RM, LeBlanc M, Faris P, Barre P, Zhang J, Scott-Douglas N; Prevention of Dialysis Catheter Lumen Occlusion with rt-PA versus Heparin Study Group. Prevention of dialysis catheter malfunction with recombinant tissue plasminogen activator. N Engl J Med. 2011 Jan 27;364(4):303-12. doi: 10.1056/NEJMoa1011376. — View Citation

Trerotola SO, Johnson MS, Harris VJ, Shah H, Ambrosius WT, McKusky MA, Kraus MA. Outcome of tunneled hemodialysis catheters placed via the right internal jugular vein by interventional radiologists. Radiology. 1997 May;203(2):489-95. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Comparison of the monthly cost of both procedures		6 months
Primary	Requirement of Urokinase	Requirement of Urokinase for thrombotic malfunction of dialyse catheter	6 months
Secondary	Removal of dialysis catheter	Removal of dialysis catheter for thrombosis and for bacteremia	6 months