Application of Citrate Dialysate in Chronic Haemodialysis

June 5, 2014 updated by: Fresenius Medical Care Deutschland GmbH
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

95

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Lüdenscheid, Germany, 58509
        • Märkische Dialysezentren GmbH
      • Lüdenscheid, Germany, 58509
        • Nephrologische Gemeinschaftspraxis
      • Solingen, Germany, 42653
        • Städt. Klinikum Solingen gemeinnützige GmbH Klinik für Nephrologie und Allgemeine Innere Medizin
      • Wetzlar, Germany, 35578
        • PHV Dialysezentrum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
patients are followed for 8 weeks
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
patients are followed for 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of clinically relevant acid-base disturbances
Time Frame: patients are followed for 8 weeks
post-dialysis bicarbonate concentration ≥ 32 mmol/l
patients are followed for 8 weeks
Occurrence of clinically relevant acid-base disturbances
Time Frame: patients are followed for 8 weeks
pre-treatment bicarbonate concentration ≥ 27 mmol/l
patients are followed for 8 weeks
Occurrence of clinically relevant intradialytic complications (adverse events)
Time Frame: patients are followed for 8 weeks
related to citrate dialysate
patients are followed for 8 weeks
Occurrence of clinically relevant adverse events
Time Frame: patients are followed for 8 weeks
related to citrate
patients are followed for 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (ACTUAL)

April 1, 2013

Study Completion (ACTUAL)

August 1, 2013

Study Registration Dates

First Submitted

October 20, 2011

First Submitted That Met QC Criteria

February 13, 2012

First Posted (ESTIMATE)

February 14, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

June 6, 2014

Last Update Submitted That Met QC Criteria

June 5, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HD-CiDi-01-D
  • There is no secondary ID

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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