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Completed

NCT Number: NCT03887468

Hemodialysis Adequacy Using a Heparin-grafted Dialyzer and a Citrate-enriched Dialysate

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 Port1.
  • 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.
  • planned vascular access intervention.
  • planned vascular access conversion.
  • Known allergy against heparin grafted AN69STmembranes.
  • Use of ACE-inhibitor
  • Use of vitamin K antagonist
  • Use of novel oral anticoagulant therapy.
  • Any medical condition, which puts the patient at risk of premature study termination in the opinion of the investigator.
  • Planned conversion of dialysis modality during study period or planned absence/leave (including pregnancy or planned pregnancy).
  • Symptomatic hypocalcemia.
  • Hb < 8g/dl at screening.
  • Hct > 45% at screening.
  • Perdialytic total parenteral nutrition therapy

Treatment and study plan

EvoCit

Device

hemodialysis using the combination of the Evodial dialyzer with a citrate enriched dialysate

EvoHep

Device

hemodialysis using the combination of the Evodial dialyzer with a conventional bicarbonate based dialysate and systemic anticoagulation using unfractionated heparin

Primary outcomes

  1. change in dialysis adequacy

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

    spKt/Vurea

Secondary outcomes

  1. proportion of thrombotic dysfunction

    Time frame: every HD session through study duration, ie 2x4 weeks

    premature termination of the dialysis session

  2. change in dialysis adequacy expressed by middle molecule (MM) clearance

    Time frame: every 1st and 4th week HD session through study duration, ie 2x4 weeks

    MM clearances

  3. occurence of complete circuit thrombosis

    Time frame: every HD session through study duration, ie 2x4 weeks

    rapidly occurring thrombosis of the extracorporeal circuit, which does not allow complete retransfusion of the blood circuit even if prescribed treatment duration is reached

  4. change in membrane coagulation

    Time frame: every midweek HD session through study duration, ie 2x4 weeks

    total cell volume measurement of the dialyzer after hemodialysis

  5. occurence of biological evaluation of coagulation activation

    Time frame: every 1st and 4th week HD session through study duration, ie 2x4 weeks

    TAT, PF1+2,

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Official study title

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)

Acronym: EvoCit-HD

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 25, 2019
Registry last updated
Jan 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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