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

Kidney Failure, Chronic Clinical Trial

Official title:

Efficacy of Urokinase Containing Locking Solutions for Thrombotic Dysfunction of Tunneled Cuffed Catheters : a Single-center Retrospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02770560
• Other study ID #: 1
• Status: Completed
• Phase: N/A
• First received: December 24, 2015
• Last updated: May 11, 2016
• Start date: May 2010
• Est. completion date: November 2014

Study information

• Verified date: December 2015
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ethics Committee Universitair Ziekenhuis Brussel : Belgium
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: November 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Renal Insufficiency
• Vascular Access Devices

Intervention

Device:
• Urokinase locking solution
On basis of the prescription : one single administration of thrombolytic locking solution versus multiple administrations (during 3 consecutive dialysis sessions)

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel	Jette	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in catheter blood flow (expressed in ml/min) after Urokinase-containing locking solution	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)	up to 54 months	No
Primary	Change of pump pressures (expressed in mmHg) after Urokinase-containing locking solution	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)	up to 54 months	No