Application of Citrate Dialysate in Chronic Haemodialysis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fresenius Medical Care Deutschland GmbH
ClinicalTrials.gov Identifier:
NCT01532297
First received: October 20, 2011
Last updated: June 5, 2014
Last verified: June 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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 ] [ 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


Secondary Outcome Measures:
  • 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


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01532297

Locations
Germany
Nephrologische Gemeinschaftspraxis
Lüdenscheid, Germany, 58509
Märkische Dialysezentren GmbH
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

No publications provided

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
Study First Received: October 20, 2011
Last Updated: June 5, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

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

ClinicalTrials.gov processed this record on September 29, 2014