Dialysis Adequacy and Clotting Complications During Anticoagulation-free Hemodialysis Using a Heparin-grafted Dialyzer and a Citrate-enriched Dialysate: a Prospective Randomized Crossover Study. (EvoCit-HD Study)

Universitair Ziekenhuis Brussel2 sites in 1 country38 target enrollmentMay 15, 2018

ConditionsKidney Diseases Hemodialysis Complication End Stage Renal Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Kidney Diseases
Sponsor: Universitair Ziekenhuis Brussel
Enrollment: 38
Locations: 2
Primary Endpoint: change in dialysis adequacy
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

After providing informed consent, patients will be randomized to either the intervention treatment ("EvoCit procedure") or the control treatment ("EvoHep procedure").

After randomization, each study arm consists of four weeks of 3x4 hours hemodialysis treatments according to the allocated protocol. After the last dialysis treatment of the fourth treatment week and after a long interdialytic interval, patients will crossover to the alternative hemodialysis procedure. After crossover, the study will be completed with, again, four weeks of 3x4 hours hemodialysis treatments according to the allocated protocol.

Registry

clinicaltrials.gov

Start Date

May 15, 2018

End Date

December 4, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Universitair Ziekenhuis Brussel

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients treated with hemodialysis or hemodiafiltration since at least three months.
•Hemodialysis or hemodiafiltration prescription of 3 x 4 hours weekly.
•≥ 18 years of age.
•Patients able and agree to provide signed informed consent.

Exclusion Criteria

•Contraindication to heparin defined as known heparin-induced thrombopenia or active bleeding risk with contra-indication for systemic anticoagulation, categorized as defined by Swartz and Port
•Planned surgery during study period, including scheduled living-donor kidney transplantation during study period.
•Hypercoagulable state defined as known malignancy, known APC resistance/FV Leiden, known prothrombin gene mutation, known protein C or protein S deficiency, known antithrombin deficiency.
•Mean Qb of \<300ml/min during one of the last 3 dialysis sessions before inclusion.
•1 or more results of spKt/Vurea \< 1,35 during the last three months prior to study inclusion.
•Need for 2 or more supplementary dialysis sessions on top of the regular 3x4 hours weekly hemodialysis regimen during the last month before inclusion.
•Vascular access dysfunction defined as
•use of urokinase the 2 months before study inclusion, including to restore catheter permeability.
•non-tunneled hemodialysis catheter use.
•known AV access outflow tract stenosis.

Outcomes

Primary Outcomes

change in dialysis adequacy

Time Frame: every midweek dialysis session through study duration, ie 2x4 weeks

spKt/Vurea

Secondary Outcomes

change in dialysis adequacy expressed by middle molecule (MM) clearance(every 1st and 4th week HD session through study duration, ie 2x4 weeks)
occurence of biological evaluation of coagulation activation(every 1st and 4th week HD session through study duration, ie 2x4 weeks)
proportion of thrombotic dysfunction(every HD session through study duration, ie 2x4 weeks)
occurence of complete circuit thrombosis(every HD session through study duration, ie 2x4 weeks)
change in membrane coagulation(every midweek HD session through study duration, ie 2x4 weeks)