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

Sponsor
Universitair Ziekenhuis Brussel (Other)
Overall Status
Completed
CT.gov ID
NCT02770560
Collaborator
(none)
148
Enrollment
1
Location
54
Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • Device: Urokinase locking solution

Study Design

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 1, 2010
Actual Primary Completion Date :
Oct 1, 2014
Actual Study Completion Date :
Nov 1, 2014

Arms and Interventions

Arm 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 Names:
  • Actosolv

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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)

    2. 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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Universitair Ziekenhuis Brussel Jette Brussels Belgium 1090

    Sponsors and Collaborators

    • Universitair Ziekenhuis Brussel

    Investigators

    • Principal Investigator: Florence Bonkain, M.D., Universitair Ziekenhuis Brussel

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Universitair Ziekenhuis Brussel
    ClinicalTrials.gov Identifier:
    NCT02770560
    Other Study ID Numbers:
    • 1
    First Posted:
    May 12, 2016
    Last Update Posted:
    May 12, 2016
    Last Verified:
    Dec 1, 2015
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Renal Insufficiency
    Kidney Failure, Chronic

    Study Results

    No Results Posted as of May 12, 2016