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Application of Citrate Dialysate in Chronic Haemodialysis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01532297
First Posted: February 14, 2012
Last Update Posted: June 6, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Fresenius Medical Care Deutschland GmbH
  Purpose
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.

Condition Intervention
Chronic Renal Disease Device: Citrate dialysate (CiDi) Device: Standard dialysate (StDi)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Application of Citrate Dialysate in Chronic Haemodialysis

Resource links provided by NLM:


Further study details as provided by Fresenius Medical Care Deutschland GmbH:

Primary Outcome Measures:
  • Occurrence of clinically relevant calcium disturbances [ Time Frame: 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 [ Time Frame: patients are followed for 8 weeks ]
    during or post-dialysis severe alkalosis with pH ≥ 7.55


Secondary Outcome Measures:
  • Occurrence of clinically relevant acid-base disturbances [ Time Frame: patients are followed for 8 weeks ]
    post-dialysis bicarbonate concentration ≥ 32 mmol/l

  • Occurrence of clinically relevant acid-base disturbances [ Time Frame: patients are followed for 8 weeks ]
    pre-treatment bicarbonate concentration ≥ 27 mmol/l

  • Occurrence of clinically relevant intradialytic complications (adverse events) [ Time Frame: patients are followed for 8 weeks ]
    related to citrate dialysate

  • Occurrence of clinically relevant adverse events [ Time Frame: patients are followed for 8 weeks ]
    related to citrate


Enrollment: 95
Study Start Date: October 2011
Study Completion Date: August 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: HD treated with standard dialysate Device: Standard dialysate (StDi)
Use during chronic dialysis 3x/week
Active Comparator: post-dilution oHDF with standard dialysate Device: Standard dialysate (StDi)
Use during chronic dialysis 3x/week
Experimental: pre-dilution oHDF with citrate dialysate Device: Citrate dialysate (CiDi)
Use during chronic dialysis 3x/week
Experimental: HD treated with citrate dialysate Device: Citrate dialysate (CiDi)
Use during chronic dialysis 3x/week
Experimental: post-dilution oHDF with citrate dialysate Device: Citrate dialysate (CiDi)
Use during chronic dialysis 3x/week
Active Comparator: pre-dilution oHDF with standard dialysate Device: Standard dialysate (StDi)
Use during chronic dialysis 3x/week

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01532297


Locations
Germany
Märkische Dialysezentren GmbH
Lüdenscheid, Germany, 58509
Nephrologische Gemeinschaftspraxis
Lüdenscheid, Germany, 58509
Städt. Klinikum Solingen gemeinnützige GmbH Klinik für Nephrologie und Allgemeine Innere Medizin
Solingen, Germany, 42653
PHV Dialysezentrum
Wetzlar, Germany, 35578
Sponsors and Collaborators
Fresenius Medical Care Deutschland GmbH
Investigators
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
  More Information

Responsible Party: Fresenius Medical Care Deutschland GmbH
ClinicalTrials.gov Identifier: NCT01532297     History of Changes
Other Study ID Numbers: HD-CiDi-01-D
There is no secondary ID
First Submitted: October 20, 2011
First Posted: February 14, 2012
Last Update Posted: June 6, 2014
Last Verified: June 2014

Keywords provided by Fresenius Medical Care Deutschland GmbH:
citrate dialysate
dialysis
calcium

Additional relevant MeSH terms:
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Citric Acid
Dialysis Solutions
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Pharmaceutical Solutions