Application of Citrate Dialysate in Chronic Haemodialysis

Fresenius Medical Care (FMC)

Status: Completed

Conditions: Chronic Renal Disease

Treatments: Device: Standard dialysate (StDi); Device: Citrate dialysate (CiDi)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01532297

There is no secondary ID

HD-CiDi-01-D

Details and patient eligibility

About

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.

Full 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.

Enrollment: 95 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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95 participants in 6 patient groups

HD treated with standard dialysate

Active Comparator group

Treatment:

Device: Standard dialysate (StDi)

post-dilution oHDF with standard dialysate

Active Comparator group

Treatment:

Device: Standard dialysate (StDi)

pre-dilution oHDF with citrate dialysate

Experimental group

Treatment:

Device: Citrate dialysate (CiDi)

HD treated with citrate dialysate

Experimental group

Treatment:

Device: Citrate dialysate (CiDi)

post-dilution oHDF with citrate dialysate

Experimental group

Treatment:

Device: Citrate dialysate (CiDi)

pre-dilution oHDF with standard dialysate

Active Comparator group

Treatment:

Device: Standard dialysate (StDi)