Chronic Renal Disease
Conditions
Keywords
citrate dialysate, dialysis, calcium
Brief summary
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.
Detailed description
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.
Interventions
DEVICECitrate dialysate (CiDi)
Use during chronic dialysis 3x/week
DEVICEStandard dialysate (StDi)
Use during chronic dialysis 3x/week
Sponsors
Fresenius Medical Care Deutschland GmbH
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* signed informed consent * patients of either sex aged ≥ 18 years * stable chronic dialysis patients undergoing a 3x/week high-flux dialysis for at least three months * patients without planned or predictable changes within diet, anticoagulation and medication regimen
Exclusion criteria
* pregnancy or lactation or woman in child bearing age without effective contraception * planned surgeries or hospital stay within the next 9 weeks * use of catheter as vascular access for dialysis * severe comorbidities not allowing to follow the study protocol * concomitant participation in another study * previous participation in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of clinically relevant calcium disturbances | patients are followed for 8 weeks | during or post-dialysis hypocalcaemia with ionized Ca ≤ 0.9 mmol/l |
| Occurrence of clinically relevant acid-base disturbances | patients are followed for 8 weeks | during or post-dialysis severe alkalosis with pH ≥ 7.55 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of clinically relevant acid-base disturbances | patients are followed for 8 weeks | post-dialysis bicarbonate concentration ≥ 32 mmol/l |
| Occurrence of clinically relevant intradialytic complications (adverse events) | patients are followed for 8 weeks | related to citrate dialysate |
| Occurrence of clinically relevant adverse events | patients are followed for 8 weeks | related to citrate |
Countries
Germany
Outcome results
None listed