Study investigating the safety and efficacy of the citrate dialysis solution compared to standard acetate dialysis solution. Use of citrate dialysis solution is not associated with a clinically relevant development of adverse events. It is hypothesized that citrate dialysate may provide a local anticoagulation effect in the dialyser improving removal of uremic toxins.
It is hypothesized that citrate dialysate may provide a local anticoagulation effect in the dialyser improving removal of uremic toxins. Study investigating the safety and efficacy of the citrate dialysis solution compared to standard acetate dialysis solution. Use of citrate dialysis solution is not associated with a clinically relevant development of adverse events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
95
Use during chronic dialysis 3x/week
Use during chronic dialysis 3x/week
Märkische Dialysezentren GmbH
Lüdenscheid, Germany
Nephrologische Gemeinschaftspraxis
Lüdenscheid, Germany
Städt. Klinikum Solingen gemeinnützige GmbH Klinik für Nephrologie und Allgemeine Innere Medizin
Solingen, Germany
PHV Dialysezentrum
Wetzlar, Germany
Occurrence of clinically relevant calcium disturbances
during or post-dialysis hypocalcaemia with ionized Ca ≤ 0.9 mmol/l
Time frame: patients are followed for 8 weeks
Occurrence of clinically relevant acid-base disturbances
during or post-dialysis severe alkalosis with pH ≥ 7.55
Time frame: patients are followed for 8 weeks
Occurrence of clinically relevant acid-base disturbances
post-dialysis bicarbonate concentration ≥ 32 mmol/l
Time frame: patients are followed for 8 weeks
Occurrence of clinically relevant acid-base disturbances
pre-treatment bicarbonate concentration ≥ 27 mmol/l
Time frame: patients are followed for 8 weeks
Occurrence of clinically relevant intradialytic complications (adverse events)
related to citrate dialysate
Time frame: patients are followed for 8 weeks
Occurrence of clinically relevant adverse events
related to citrate
Time frame: patients are followed for 8 weeks
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