Clinical trial NCT02036255: Prevention of Dialysis Catheter Malfunction With Prophylactic Use of a Taurolidine Containing Urokinase
Official title: Prevention of Tunneled Cuffed Catheter Malfunction With Prophylactic Use of a Taurolidine Locking Solution Containing Urokinase : a Multicentric Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Patency
Infection
Keywords: Prevention, Thrombosis, Hemodialysis, Vascular access device
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2014-01-14
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Requirement of Urokinase
timeFrame: 6 months
Secondary outcomes:
measure: Removal of dialysis catheter
timeFrame: 6 months
Other outcomes:
measure: Comparison of the monthly cost of both procedures
timeFrame: 6 months
Locations:
city: Anderlecht
country: Belgium
facility: Bracops Hospital
state: Brussels
city: Ixelles
country: Belgium
facility: Ixelles Hospital
state: Brussels
city: Jette
country: Belgium
facility: Brugman Hospital
state: Brussels
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel
state: Brussels
city: Charleroi
country: Belgium
facility: CHU Charleroi
state: Hainaut
city: Tournai
country: Belgium
facility: CHWAPI
state: Hainaut
city: Antwerpen
country: Belgium
facility: UZ Antwerpen
city: Brussels
country: Belgium
facility: Ixelles Hospital
city: Ghent
country: Belgium
facility: Ghent Hospital
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Florence FB Bonkain, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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. doi: 10.1148/radiology.203.2.9114110.
citation: 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.
citation: Bonkain F, Stolear JC, Catalano C, Vandervelde D, Treille S, Couttenye MM, Dhondt A, Libertalis M, Allamani M, Madhoun P, Van Craenenbroeck AH, Vanommeslaeghe F, Van Hulle F, Durieux P, Van Limberghen I, Tielemans C, Wissing KM. Prevention of tunneled cuffed catheter dysfunction with prophylactic use of a taurolidine urokinase lock: A randomized double-blind trial. PLoS One. 2021 May 20;16(5):e0251793. doi: 10.1371/journal.pone.0251793. eCollection 2021.
citation: Bonkain F, Van Hulle F, Janssens P, Catalano C, Allamani M, Stolear JC, Vandervelde D, Libertalis M, Treille S, Couttenye MM, Dhondt A, Van Biesen W, Fils JF, Tielemans C, Wissing KM. Urokinase-containing locking solution in the prevention of dialysis catheter dysfunction: a double blind randomized controlled trial. J Vasc Access. 2017 Sep 11;18(5):436-442. doi: 10.5301/jva.5000737. Epub 2017 Jun 14.