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

Not Applicable

Completed

• Conditions: End Stage Renal Disease; Kidney Diseases; Hemodialysis Complication
• Interventions: Device: EvoHep; Device: EvoCit

• Registration Number: NCT03887468
• Lead Sponsor: Universitair Ziekenhuis Brussel

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-15
• Study First Submitted: 2019-01-22
• Study First Submitted QC: 2019-03-20
• Study First Posted: 2019-03-25
• Primary Completion: 2019-12-04
• Study Completion: 2019-12-04
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-15
• Last Update Posted: 2020-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
"EvoHep"	EvoHep	Control: "EvoHep procedure" using a heparin-grafted AN69ST dialyzer in combination with a conventional bicarbonate-based dialysate and standardized systemic anticoagulation using unfractionated heparin.
"EvoCit"	EvoCit	Standardized hemodialysis treatments 3x4hours/week. Intervention: "EvoCit procedure" using a heparin-grafted AN69ST dialyzer in combination with a citric acid enriched dialysate without any systemic anticoagulation.

Primary Outcome Measures

Name	Time	Method
change in dialysis adequacy	every midweek dialysis session through study duration, ie 2x4 weeks	spKt/Vurea

Secondary Outcome Measures

Name	Time	Method
change in dialysis adequacy expressed by middle molecule (MM) clearance	every 1st and 4th week HD session through study duration, ie 2x4 weeks	MM clearances
occurence of biological evaluation of coagulation activation	every 1st and 4th week HD session through study duration, ie 2x4 weeks	TAT, PF1+2,
proportion of thrombotic dysfunction	every HD session through study duration, ie 2x4 weeks	premature termination of the dialysis session
occurence of complete circuit thrombosis	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
change in membrane coagulation	every midweek HD session through study duration, ie 2x4 weeks	total cell volume measurement of the dialyzer after hemodialysis

Trial Locations

Locations (2)

UZ Brussel; 🇧🇪 Jette, Belgium

CHU Brugmann; 🇧🇪 Laeken, Belgium