Application of Citrate Dialysate in Chronic Haemodialysis

Not Applicable

Completed

• Conditions: Chronic Renal Disease
• Interventions: Device: Standard dialysate (StDi); Device: Citrate dialysate (CiDi)

• Registration Number: NCT01532297
• Lead Sponsor: Fresenius Medical Care Deutschland GmbH

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.

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-20
• Study First Submitted QC: 2012-02-13
• Study First Posted: 2012-02-14
• Primary Completion: 2013-04
• Study Completion: 2013-08
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-05
• Last Update Posted: 2014-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
post-dilution oHDF with standard dialysate	Standard dialysate (StDi)	-
HD treated with standard dialysate	Standard dialysate (StDi)	-
HD treated with citrate dialysate	Citrate dialysate (CiDi)	-
post-dilution oHDF with citrate dialysate	Citrate dialysate (CiDi)	-
pre-dilution oHDF with citrate dialysate	Citrate dialysate (CiDi)	-
pre-dilution oHDF with standard dialysate	Standard dialysate (StDi)	-

Primary Outcome Measures

Name	Time	Method
Occurrence of clinically relevant acid-base disturbances	patients are followed for 8 weeks	during or post-dialysis severe alkalosis with pH ≥ 7.55
Occurrence of clinically relevant calcium disturbances	patients are followed for 8 weeks	during or post-dialysis hypocalcaemia with ionized Ca ≤ 0.9 mmol/l

Secondary Outcome Measures

Name	Time	Method
Occurrence of clinically relevant adverse events	patients are followed for 8 weeks	related to citrate
Occurrence of clinically relevant acid-base disturbances	patients are followed for 8 weeks	pre-treatment bicarbonate concentration ≥ 27 mmol/l
Occurrence of clinically relevant intradialytic complications (adverse events)	patients are followed for 8 weeks	related to citrate dialysate

Trial Locations

Locations (4)

Städt. Klinikum Solingen gemeinnützige GmbH Klinik für Nephrologie und Allgemeine Innere Medizin; 🇩🇪 Solingen, Germany

PHV Dialysezentrum; 🇩🇪 Wetzlar, Germany

Märkische Dialysezentren GmbH; 🇩🇪 Lüdenscheid, Germany

Nephrologische Gemeinschaftspraxis; 🇩🇪 Lüdenscheid, Germany