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Application of Citrate Dialysate in Chronic Haemodialysis

Primary Purpose

Chronic Renal Disease

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Citrate dialysate (CiDi)
Standard dialysate (StDi)
Sponsored by
Fresenius Medical Care Deutschland GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Renal Disease focused on measuring citrate dialysate, dialysis, calcium

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Märkische Dialysezentren GmbH
  • Nephrologische Gemeinschaftspraxis
  • Städt. Klinikum Solingen gemeinnützige GmbH Klinik für Nephrologie und Allgemeine Innere Medizin
  • PHV Dialysezentrum

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Active Comparator

Experimental

Experimental

Experimental

Active Comparator

Arm Label

HD treated with standard dialysate

post-dilution oHDF with standard dialysate

pre-dilution oHDF with citrate dialysate

HD treated with citrate dialysate

post-dilution oHDF with citrate dialysate

pre-dilution oHDF with standard dialysate

Arm Description

Outcomes

Primary Outcome Measures

Occurrence of clinically relevant calcium disturbances
during or post-dialysis hypocalcaemia with ionized Ca ≤ 0.9 mmol/l
Occurrence of clinically relevant acid-base disturbances
during or post-dialysis severe alkalosis with pH ≥ 7.55

Secondary Outcome Measures

Occurrence of clinically relevant acid-base disturbances
post-dialysis bicarbonate concentration ≥ 32 mmol/l
Occurrence of clinically relevant acid-base disturbances
pre-treatment bicarbonate concentration ≥ 27 mmol/l
Occurrence of clinically relevant intradialytic complications (adverse events)
related to citrate dialysate
Occurrence of clinically relevant adverse events
related to citrate

Full Information

First Posted
October 20, 2011
Last Updated
June 5, 2014
Sponsor
Fresenius Medical Care Deutschland GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01532297
Brief Title
Application of Citrate Dialysate in Chronic Haemodialysis
Official Title
Application of Citrate Dialysate in Chronic Haemodialysis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fresenius Medical Care Deutschland GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Renal Disease
Keywords
citrate dialysate, dialysis, calcium

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HD treated with standard dialysate
Arm Type
Active Comparator
Arm Title
post-dilution oHDF with standard dialysate
Arm Type
Active Comparator
Arm Title
pre-dilution oHDF with citrate dialysate
Arm Type
Experimental
Arm Title
HD treated with citrate dialysate
Arm Type
Experimental
Arm Title
post-dilution oHDF with citrate dialysate
Arm Type
Experimental
Arm Title
pre-dilution oHDF with standard dialysate
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Citrate dialysate (CiDi)
Intervention Description
Use during chronic dialysis 3x/week
Intervention Type
Device
Intervention Name(s)
Standard dialysate (StDi)
Intervention Description
Use during chronic dialysis 3x/week
Primary Outcome Measure Information:
Title
Occurrence of clinically relevant calcium disturbances
Description
during or post-dialysis hypocalcaemia with ionized Ca ≤ 0.9 mmol/l
Time Frame
patients are followed for 8 weeks
Title
Occurrence of clinically relevant acid-base disturbances
Description
during or post-dialysis severe alkalosis with pH ≥ 7.55
Time Frame
patients are followed for 8 weeks
Secondary Outcome Measure Information:
Title
Occurrence of clinically relevant acid-base disturbances
Description
post-dialysis bicarbonate concentration ≥ 32 mmol/l
Time Frame
patients are followed for 8 weeks
Title
Occurrence of clinically relevant acid-base disturbances
Description
pre-treatment bicarbonate concentration ≥ 27 mmol/l
Time Frame
patients are followed for 8 weeks
Title
Occurrence of clinically relevant intradialytic complications (adverse events)
Description
related to citrate dialysate
Time Frame
patients are followed for 8 weeks
Title
Occurrence of clinically relevant adverse events
Description
related to citrate
Time Frame
patients are followed for 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Schmitz, Dr.
Organizational Affiliation
Städt. Klinikum Solingen gemeinnützige GmbH Klinik für Nephrologie und Allgemeine Innere Medizin
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Olaf Loke, Dr.
Organizational Affiliation
Nephrologische Gemeinschaftspraxis
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Klaus Kalb, Dr.
Organizational Affiliation
Märkische Dialysezentren GmbH
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bernhard Fach, Dr.
Organizational Affiliation
PHV Dialysezentrum
Official's Role
Principal Investigator
Facility Information:
Facility Name
Märkische Dialysezentren GmbH
City
Lüdenscheid
ZIP/Postal Code
58509
Country
Germany
Facility Name
Nephrologische Gemeinschaftspraxis
City
Lüdenscheid
ZIP/Postal Code
58509
Country
Germany
Facility Name
Städt. Klinikum Solingen gemeinnützige GmbH Klinik für Nephrologie und Allgemeine Innere Medizin
City
Solingen
ZIP/Postal Code
42653
Country
Germany
Facility Name
PHV Dialysezentrum
City
Wetzlar
ZIP/Postal Code
35578
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

Application of Citrate Dialysate in Chronic Haemodialysis

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