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

Universitair Ziekenhuis Brussel38 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Kidney Diseases Hemodialysis Complication End Stage Renal Disease

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

change in dialysis adequacy

spKt/Vurea

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

Secondary Outcomes

proportion of thrombotic dysfunction

premature termination of the dialysis session

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

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

MM clearances

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

occurence of complete circuit thrombosis

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

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

change in membrane coagulation

total cell volume measurement of the dialyzer after hemodialysis

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

occurence of biological evaluation of coagulation activation

TAT, PF1+2,