An interventional study of EvoCit and EvoHep in Kidney Diseases, Hemodialysis Complication and End Stage Renal Disease, sponsored by Universitair Ziekenhuis Brussel. Completed at 2 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-18.
Sponsored by Universitair Ziekenhuis Brussel · Not applicable, Interventional, and Treatment
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.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 38 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Universitair Ziekenhuis Brussel is the lead sponsor of 362 studies on the registry; 103 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Vascular access dysfunction defined as
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.
Device: EvoCit
Control: "EvoHep procedure" using a heparin-grafted AN69ST dialyzer in combination with a conventional bicarbonate-based dialysate and standardized systemic anticoagulation using unfractionated heparin.
Device: EvoHep
hemodialysis using the combination of the Evodial dialyzer with a citrate enriched dialysate
hemodialysis using the combination of the Evodial dialyzer with a conventional bicarbonate based dialysate and systemic anticoagulation using unfractionated heparin
change in dialysis adequacy
spKt/Vurea
Time frame: every midweek dialysis session through study duration, ie 2x4 weeks
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,
Time frame: every 1st and 4th week HD session through study duration, ie 2x4 weeks
Plan to share: No
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Universitair Ziekenhuis Brussel