Clinical trial NCT01532297: Application of Citrate Dialysate in Chronic Haemodialysis
Official title: Application of Citrate Dialysate in Chronic Haemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Renal Disease
Keywords: citrate dialysate
dialysis
calcium
Lead sponsor: Fresenius Medical Care Deutschland GmbH
Sponsor class: INDUSTRY
First posted: 2012-02-14
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of clinically relevant calcium disturbances
timeFrame: patients are followed for 8 weeks
measure: Occurrence of clinically relevant acid-base disturbances
timeFrame: patients are followed for 8 weeks
Secondary outcomes:
measure: Occurrence of clinically relevant acid-base disturbances
timeFrame: patients are followed for 8 weeks
measure: Occurrence of clinically relevant acid-base disturbances
timeFrame: patients are followed for 8 weeks
measure: Occurrence of clinically relevant intradialytic complications (adverse events)
timeFrame: patients are followed for 8 weeks
measure: Occurrence of clinically relevant adverse events
timeFrame: patients are followed for 8 weeks
Other outcomes:
Locations:
city: Lüdenscheid
country: Germany
facility: Märkische Dialysezentren GmbH
city: Lüdenscheid
country: Germany
facility: Nephrologische Gemeinschaftspraxis
city: Solingen
country: Germany
facility: Städt. Klinikum Solingen gemeinnützige GmbH Klinik für Nephrologie und Allgemeine Innere Medizin
city: Wetzlar
country: Germany
facility: PHV Dialysezentrum
Study officials:
affiliation: Städt. Klinikum Solingen gemeinnützige GmbH Klinik für Nephrologie und Allgemeine Innere Medizin
name: Michael Schmitz, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Nephrologische Gemeinschaftspraxis
name: Olaf Loke, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Märkische Dialysezentren GmbH
name: Klaus Kalb, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: PHV Dialysezentrum
name: Bernhard Fach, Dr.
role: PRINCIPAL_INVESTIGATOR
References: