EvoCit
Devicehemodialysis using the combination of the Evodial dialyzer with a citrate enriched dialysate
NCT Number: NCT03887468
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
UZ Brussel, Jette, Belgium
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: every midweek dialysis session through study duration, ie 2x4 weeks
spKt/Vurea
Time frame: every HD session through study duration, ie 2x4 weeks
premature termination of the dialysis session
Time frame: every 1st and 4th week HD session through study duration, ie 2x4 weeks
MM clearances
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
Time frame: every midweek HD session through study duration, ie 2x4 weeks
total cell volume measurement of the dialyzer after hemodialysis
Time frame: every 1st and 4th week HD session through study duration, ie 2x4 weeks
TAT, PF1+2,
Universitair Ziekenhuis Brussel
Other
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
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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