Clinical trial NCT03887468: Hemodialysis Adequacy Using a Heparin-grafted Dialyzer and a Citrate-enriched Dialysate
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Diseases
Hemodialysis Complication
End Stage Renal Disease
Keywords: dialysis adequacy
clotting
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2019-03-25
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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 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

  1. use of urokinase the 2 months before study inclusion, including to restore catheter permeability.
  2. non-tunneled hemodialysis catheter use.
  3. known AV access outflow tract stenosis.
  4. planned vascular access intervention.
  5. 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

Primary outcomes:
measure: change in dialysis adequacy
timeFrame: every midweek dialysis session through study duration, ie 2x4 weeks
Secondary outcomes:
measure: proportion of thrombotic dysfunction
timeFrame: every HD session through study duration, ie 2x4 weeks
measure: change in dialysis adequacy expressed by middle molecule (MM) clearance
timeFrame: every 1st and 4th week HD session through study duration, ie 2x4 weeks
measure: occurence of complete circuit thrombosis
timeFrame: every HD session through study duration, ie 2x4 weeks
measure: change in membrane coagulation
timeFrame: every midweek HD session through study duration, ie 2x4 weeks
measure: occurence of biological evaluation of coagulation activation
timeFrame: every 1st and 4th week HD session through study duration, ie 2x4 weeks
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: UZ Brussel
city: Laeken
country: Belgium
facility: CHU Brugmann
Study officials:
References:
citation: Francois K, De Clerck D, Tonnelier A, Cambier ML, Orlando C, Jochmans K, Cools W, Wissing KM. Dialyzer Performance During Hemodialysis Without Systemic Anticoagulation Using a Heparin-Grafted Dialyzer Combined With a Citrate-Enriched Dialysate: Results of the Randomized Crossover Noninferiority EvoCit Study. Am J Kidney Dis. 2022 Jan;79(1):79-87.e1. doi: 10.1053/j.ajkd.2021.04.004. Epub 2021 Apr 30.