Hemodialysis Adequacy Using a Heparin-grafted Dialyzer and a Citrate-enriched Dialysate
NCT03887468 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38
Last updated 2020-01-18
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.
Conditions
- Kidney Diseases
- Hemodialysis Complication
- End Stage Renal Disease
Interventions
- DEVICE
-
EvoCit
hemodialysis using the combination of the Evodial dialyzer with a citrate enriched dialysate
- DEVICE
-
EvoHep
hemodialysis using the combination of the Evodial dialyzer with a conventional bicarbonate based dialysate and systemic anticoagulation using unfractionated heparin
Sponsors & Collaborators
-
Universitair Ziekenhuis Brussel
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-05-15
- Primary Completion
- 2019-12-04
- Completion
- 2019-12-04
Countries
- Belgium
Study Locations
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