Efficacy of Urokinase Containing Locking Solutions for Thrombotic Dysfunction of Tunneled Hemodialysis Catheters

Completed

• Conditions: Kidney Failure, Chronic; Vascular Access Devices
• Interventions: Device: Urokinase locking solution

• Registration Number: NCT02770560
• Lead Sponsor: Universitair Ziekenhuis Brussel

Brief Summary

Thrombotic dysfunction is a common complication of tunneled cuffed catheters (TCC) leading to inadequate dialysis dose, need to catheter replacement with as consequence progressive exclusion of vascular sites. Thrombolytic agent can be used as therapeutic locking solution to dissolve the clotting formed in of around the catheter lumen. There are few studies on the optimal approach of TCC-related thrombosis with thrombolytic containing locking solution (dose, number of administrations, timing of administration - intra or interdialytic use). The primary objective of this retrospective study was to compare the efficacy of inter versus intradialytic Urokinase containing locking solution on restoration of the TCC blood flow. The investigators also assess the question of multiple administrations of Urokinase are more efficient than one single administration

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Primary Completion: 2014-10
• Study Completion: 2014-11
• Status Verified: 2015-12
• Study First Submitted: 2015-12-24
• Study First Submitted QC: 2016-05-11
• Last Update Submitted: 2016-05-11
• Study First Posted: 2016-05-12
• Last Update Posted: 2016-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

Inclusion Criteria

• Hemodialysis patients over 18 years old, receiving hemodialysis between 1st May 2010 and 31st October 2014 via a tunneled cuffed catheter at the Hemodialysis Unit of Universitair Ziekenhuis Brussel Hospital.

Exclusion Criteria

• Patients younger than 18 years old
• Patients with a temporary dialysis catheter
• Patients who never received a tunneled hemodialysis catheter in this period
• Patients who didn't have a medical file at the Universitair Ziekenhuis Brussel Hospital

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chronic hemodialysis patients with a tunneled cuffed catheter	Urokinase locking solution	In case of thrombotic dysfunction of the dialysis catheter : administration of Urokinase (100 000 units in total) as locking solution in the dead space of the catheter lumen, interdialytic (between two dialysis sessions) or intradialytic (during the dialysis in case of complete obstruction of the dialysis catheter)

Primary Outcome Measures

Name	Time	Method
Change in catheter blood flow (expressed in ml/min) after Urokinase-containing locking solution	up to 54 months	Comparison of catheter blood flow measurement before and after Urokinase locking solution administration according to the type of Urokinase prescription (inter- versus intra-dialytic use, one- single versus multiple administrations)
Change of pump pressures (expressed in mmHg) after Urokinase-containing locking solution	up to 54 months	Comparison of pump pressures measurement before and after Urokinase locking solution administration according to the type of prescription of Urokinase containing locking solution (inter versus intra-dialytic, one single use versus multiple administrations)

Trial Locations

Locations (1)

Universitair Ziekenhuis Brussel; 🇧🇪 Jette, Brussels, Belgium