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

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ClinicalTrials.gov Identifier: NCT02770560
Recruitment Status : Completed
First Posted : May 12, 2016
Last Update Posted : May 12, 2016
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment
Kidney Failure, Chronic Vascular Access Devices Device: Urokinase locking solution

Study Type : Observational
Actual Enrollment : 148 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Efficacy of Urokinase Containing Locking Solutions for Thrombotic Dysfunction of Tunneled Cuffed Catheters : a Single-center Retrospective Study
Study Start Date : May 2010
Actual Primary Completion Date : October 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Urokinase

Group/Cohort Intervention/treatment
Chronic hemodialysis patients with a tunneled cuffed catheter
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)
Device: Urokinase locking solution
On basis of the prescription : one single administration of thrombolytic locking solution versus multiple administrations (during 3 consecutive dialysis sessions)
Other Name: Actosolv




Primary Outcome Measures :
  1. Change in catheter blood flow (expressed in ml/min) after Urokinase-containing locking solution [ Time Frame: 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)

  2. Change of pump pressures (expressed in mmHg) after Urokinase-containing locking solution [ Time Frame: 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)



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Incident and prevalent patients on hemodialysis, more than 18y old, receiving dialysis via a tunneled cuffed catheter between 1st May 2010 and 31st October 2014.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02770560


Locations
Belgium
Universitair Ziekenhuis Brussel
Jette, Brussels, Belgium, 1090
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Investigators
Principal Investigator: Florence Bonkain, M.D. Universitair Ziekenhuis Brussel

Responsible Party: Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT02770560     History of Changes
Other Study ID Numbers: 1
First Posted: May 12, 2016    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Pharmaceutical Solutions