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Application of Citrate Dialysate in Chronic Haemodialysis

This study is currently recruiting participants.
Verified February 2012 by Fresenius Medical Care Deutschland GmbH
Sponsor:
Information provided by (Responsible Party):
Fresenius Medical Care Deutschland GmbH
ClinicalTrials.gov Identifier:
NCT01532297
First received: October 20, 2011
Last updated: February 13, 2012
Last verified: February 2012
History of Changes

October 20, 2011
February 13, 2012
October 2011
July 2012   (final data collection date for primary outcome measure)
  • Occurrence of clinically relevant calcium disturbances [ Time Frame: patients are followed for 8 weeks ] [ Designated as safety issue: Yes ]
    during or post-dialysis hypocalcaemia with ionized Ca ≤ 0.9 mmol/l
  • Occurrence of clinically relevant acid-base disturbances [ Time Frame: patients are followed for 8 weeks ] [ Designated as safety issue: Yes ]
    during or post-dialysis severe alkalosis with pH ≥ 7.55
Same as current
Complete list of historical versions of study NCT01532297 on ClinicalTrials.gov Archive Site
  • Occurrence of clinically relevant acid-base disturbances [ Time Frame: patients are followed for 8 weeks ] [ Designated as safety issue: Yes ]
    post-dialysis bicarbonate concentration ≥ 32 mmol/l
  • Occurrence of clinically relevant acid-base disturbances [ Time Frame: patients are followed for 8 weeks ] [ Designated as safety issue: Yes ]
    pre-treatment bicarbonate concentration ≥ 27 mmol/l
  • Occurrence of clinically relevant intradialytic complications (adverse events) [ Time Frame: patients are followed for 8 weeks ] [ Designated as safety issue: Yes ]
    related to citrate dialysate
  • Occurrence of clinically relevant adverse events [ Time Frame: patients are followed for 8 weeks ] [ Designated as safety issue: Yes ]
    related to citrate
Same as current
Not Provided
Not Provided
 
Application of Citrate Dialysate in Chronic Haemodialysis
Application of Citrate Dialysate in Chronic Haemodialysis

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Renal Disease
  • Device: Citrate dialysate (CiDi)
    Use during chronic dialysis 3x/week
  • Device: Standard dialysate (StDi)
    Use during chronic dialysis 3x/week
  • Active Comparator: HD treated with standard dialysate
    Intervention: Device: Standard dialysate (StDi)
  • Active Comparator: post-dilution oHDF with standard dialysate
    Intervention: Device: Standard dialysate (StDi)
  • Experimental: pre-dilution oHDF with citrate dialysate
    Intervention: Device: Citrate dialysate (CiDi)
  • Experimental: HD treated with citrate dialysate
    Intervention: Device: Citrate dialysate (CiDi)
  • Experimental: post-dilution oHDF with citrate dialysate
    Intervention: Device: Citrate dialysate (CiDi)
  • Active Comparator: pre-dilution oHDF with standard dialysate
    Intervention: Device: Standard dialysate (StDi)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Justyna Kozik-Jaromin, Dr. med. 004961726097634 justyna.kozik-jaromin@fmc-ag.com
Germany
 
NCT01532297
HD-CiDi-01-D, There is no secondary ID
No
Fresenius Medical Care Deutschland GmbH
Fresenius Medical Care Deutschland GmbH
Not Provided
Principal Investigator: Michael Schmitz, Dr. Städt. Klinikum Solingen gemeinnützige GmbH Klinik für Nephrologie und Allgemeine Innere Medizin
Principal Investigator: Olaf Loke, Dr. Nephrologische Gemeinschaftspraxis
Principal Investigator: Klaus Kalb, Dr. Märkische Dialysezentren GmbH
Principal Investigator: Bernhard Fach, Dr. PHV Dialysezentrum
Fresenius Medical Care Deutschland GmbH
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP