Substitution of Acetate by Citrate in the Bicarbonate Based Hemodialysis

May 3, 2016 updated by: PD Dr. Christoph Schmaderer, Technical University of Munich

Effect of an Acetate-free Dialysis (Citrate Based) on Parameters of Central Hemodynamics, Dialysis Adequacy, Quality of Life and Immunological Parameters in Chronic Hemodialysis

Acetate is the primary acidifying solution used in bicarbonate-based hemodialysis worldwide. It has been published in small trials or case series that the addition of acetate is associated with a rise in nitric oxide production of vascular smooth muscle cells, endothelial cells and myocardial cells as a sign of vascular dysfunction. Furthermore clinical side effects of dialysis e.g. nausea, malnutrition, intradialytic blood pressure drops, induction of proinflammatory cytokines and activation of complement and leukocytes have been described with acetate.

Citrate on the other hand was associated with: Acid-base disorders (metabolic alkalosis), Disturbances of the calcium homeostasis (Hypocalcemia), but also anti-inflammatory effects. Both dialysate additives (citrate and acetate) are commercially available and are used world wide in dialysis centers.

The investigators hypothesize that substitution of acetate by citrate reduces the cardiovascular risk (measured by a change in the surrogate parameter of pulse wave velocity and Augmentation index) and might improves quality of life in the participants. Furthermore the investigators speculate that citrate in the dialysis solution could reduce systemic inflammation in the participants of the study.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

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
    • Bavaria
      • Munich, Bavaria, Germany, 81737
        • Recruiting
        • Nierenzentrum24 NEUPERLACH
        • Contact:
          • Carla Maceiczyk, M.D.
        • Principal Investigator:
          • Carla Maceizyk, M.D.
      • Munich, Bavaria, Germany, 81925
        • Recruiting
        • Nierenzentrum Bogenhausen
        • Contact:
          • Richard Bieber, M.D.
          • Phone Number: 0049 89 4522380
        • Principal Investigator:
          • Richard Bieber, MD

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:

  • time since initiation of dialysis > 3 months
  • age > 18 years
  • dialysis 3x/week for > 4 hrs

Exclusion Criteria:

  • ongoing infection
  • pregnancy
  • lack of written and informed consent

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: SUPPORTIVE_CARE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Acetate
Other: Acetate by Citrate substitution and vice versa
substitution of acetate by citrate in dialysis fluid
EXPERIMENTAL: Citrate
Other: Acetate by Citrate substitution and vice versa
substitution of acetate by citrate in dialysis fluid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Augmentation Index (AIx)
Time Frame: 6 months (cross over after 3 months)
cross over design
6 months (cross over after 3 months)

Collaborators and Investigators

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

Sponsor

Technical University of Munich

Collaborators

Gambro Renal Products, Inc.

Investigators

  • Principal Investigator: Christoph Schmaderer, M.D., attending, board certified nephrologist

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2016

Primary Completion (ANTICIPATED)

January 1, 2017

Study Completion (ANTICIPATED)

April 1, 2017

Study Registration Dates

First Submitted

April 15, 2016

First Submitted That Met QC Criteria

April 15, 2016

First Posted (ESTIMATE)

April 20, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

May 4, 2016

Last Update Submitted That Met QC Criteria

May 3, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 344/15s

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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